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Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903822
Recruitment Status : Completed
First Posted : April 4, 2019
Results First Posted : March 29, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: PF-06700841
Drug: Vehicle (Placebo)
Enrollment 292
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Hide Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible atopic dermatitis (AD) areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 percent (%) cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Period Title: Treatment Phase (6 Weeks)
Started 37 37 36 37 36 36 36 37
Completed 28 27 33 32 31 25 31 33
Not Completed 9 10 3 5 5 11 5 4
Reason Not Completed
Adverse Event             3             3             1             1             1             6             1             0
Lack of Efficacy             0             0             0             0             1             1             0             0
Lost to Follow-up             0             0             0             0             0             0             1             1
Physician Decision             0             2             0             0             0             0             0             0
Pregnancy             0             0             0             1             1             0             0             0
Protocol Violation             0             0             0             1             0             0             0             0
Withdrawal by Subject             2             4             2             2             1             2             3             3
Refused Further Treatment             2             0             0             0             0             1             0             0
Other             2             1             0             0             1             1             0             0
Period Title: Follow up Phase (4 Weeks)
Started 37 [1] 37 [1] 36 [1] 37 [1] 36 [1] 36 [1] 36 [1] 37 [1]
Completed 29 29 32 33 32 28 31 31
Not Completed 8 8 4 4 4 8 5 6
Reason Not Completed
Adverse Event             3             2             1             1             0             5             1             0
Lack of Efficacy             0             0             0             0             1             0             0             0
Lost to Follow-up             2             0             0             0             0             0             1             3
Pregnancy             0             0             0             1             1             0             0             0
Withdrawal by Subject             2             5             3             2             2             2             3             3
Refused Further Study Procedures             0             0             0             0             0             1             0             0
Other             1             1             0             0             0             0             0             0
[1]
Participants not completing treatment phase could also start this phase.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID Total
Hide Arm/Group Description Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose. Total of all reporting groups
Overall Number of Baseline Participants 37 37 36 37 36 36 36 37 292
Hide Baseline Analysis Population Description
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 37 participants 36 participants 37 participants 36 participants 36 participants 36 participants 37 participants 292 participants
39.1  (16.80) 40.8  (15.35) 43.4  (16.43) 38.4  (12.90) 40.5  (12.30) 42.3  (18.18) 39.4  (17.27) 38.1  (15.34) 40.2  (15.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 36 participants 37 participants 36 participants 36 participants 36 participants 37 participants 292 participants
Female
20
  54.1%
19
  51.4%
24
  66.7%
23
  62.2%
15
  41.7%
19
  52.8%
16
  44.4%
20
  54.1%
156
  53.4%
Male
17
  45.9%
18
  48.6%
12
  33.3%
14
  37.8%
21
  58.3%
17
  47.2%
20
  55.6%
17
  45.9%
136
  46.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 36 participants 37 participants 36 participants 36 participants 36 participants 37 participants 292 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
3
   8.3%
2
   5.4%
1
   2.8%
3
   8.3%
0
   0.0%
4
  10.8%
13
   4.5%
Not Hispanic or Latino
37
 100.0%
37
 100.0%
32
  88.9%
35
  94.6%
35
  97.2%
33
  91.7%
35
  97.2%
33
  89.2%
277
  94.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.8%
0
   0.0%
2
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 36 participants 37 participants 36 participants 36 participants 36 participants 37 participants 292 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
  10.8%
8
  21.6%
4
  11.1%
8
  21.6%
10
  27.8%
9
  25.0%
9
  25.0%
7
  18.9%
59
  20.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
2
   0.7%
Black or African American
8
  21.6%
7
  18.9%
9
  25.0%
6
  16.2%
4
  11.1%
6
  16.7%
5
  13.9%
6
  16.2%
51
  17.5%
White
24
  64.9%
22
  59.5%
21
  58.3%
20
  54.1%
21
  58.3%
20
  55.6%
22
  61.1%
24
  64.9%
174
  59.6%
More than one race
0
   0.0%
0
   0.0%
2
   5.6%
2
   5.4%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
5
   1.7%
Unknown or Not Reported
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
1.Primary Outcome
Title Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
Hide Description EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method assuming responses are similar to the corresponding vehicle arm under the MAR assumption
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Hide Arm/Group Description:
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Overall Number of Participants Analyzed 37 37 36 37 36 36 36 37
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percent change
-44.4
(-57.3 to -31.6)
-58.3
(-71.2 to -45.5)
-64.6
(-77.1 to -52.1)
-70.1
(-82.1 to -58.0)
-67.9
(-80.6 to -55.3)
-47.6
(-57.5 to -37.7)
-58.6
(-67.5 to -49.7)
-75.0
(-83.8 to -66.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments Analysis of covariance (ANCOVA) contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1040
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value -13.9
Confidence Interval (2-Sided) 90%
-32.1 to 4.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0334
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -20.2
Confidence Interval (2-Sided) 90%
-38.3 to -2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0086
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -25.6
Confidence Interval (2-Sided) 90%
-43.3 to -8.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0158
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -23.5
Confidence Interval (2-Sided) 90%
-41.5 to -5.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0879
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.0
Confidence Interval (2-Sided) 90%
-24.3 to 2.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -27.4
Confidence Interval (2-Sided) 90%
-40.7 to -14.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.11
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation
Hide Description IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Hide Arm/Group Description:
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Overall Number of Participants Analyzed 37 37 36 37 36 36 36 37
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
10.8
(4.8 to 22.2)
29.7
(18.5 to 43.3)
33.3
(21.3 to 47.0)
40.5
(28.0 to 54.4)
44.4
(30.2 to 59.1)
13.9
(6.9 to 25.4)
33.3
(21.3 to 47.0)
27.0
(15.5 to 40.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0244
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.9
Confidence Interval (2-Sided) 90%
2.4 to 34.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0113
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 22.5
Confidence Interval (2-Sided) 90%
4.8 to 38.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.7
Confidence Interval (2-Sided) 90%
11.0 to 45.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 33.6
Confidence Interval (2-Sided) 90%
13.7 to 49.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0289
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 19.4
Confidence Interval (2-Sided) 90%
1.8 to 36.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1145
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.1
Confidence Interval (2-Sided) 90%
-2.9 to 29.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
Hide Description EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method assuming responses are similar to the corresponding vehicle arm under the MAR assumption
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Hide Arm/Group Description:
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Overall Number of Participants Analyzed 37 37 36 37 36 36 36 37
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
-3.2
(-4.1 to -2.3)
-4.5
(-5.4 to -3.6)
-4.6
(-5.5 to -3.7)
-4.8
(-5.7 to -3.9)
-5.5
(-6.4 to -4.7)
-3.6
(-4.3 to -3.0)
-4.4
(-5.0 to -3.8)
-5.3
(-5.9 to -4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0488
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.31
Confidence Interval (2-Sided) 90%
-2.61 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.790
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0413
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.37
Confidence Interval (2-Sided) 90%
-2.66 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.788
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0200
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.59
Confidence Interval (2-Sided) 90%
-2.86 to -0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.773
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.33
Confidence Interval (2-Sided) 90%
-3.58 to -1.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.758
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0727
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.78
Confidence Interval (2-Sided) 90%
-1.66 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.535
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments ANCOVA contained fixed factors of treatment and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.64
Confidence Interval (2-Sided) 90%
-2.52 to -0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.534
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
Hide Description The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline, Weeks 1, 2, 3, 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. NRI method: participants with missing values were considered to be non-responders.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Hide Arm/Group Description:
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Overall Number of Participants Analyzed 37 36 35 37 36 36 35 35
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
At Week 1
16.2
(7.3 to 29.3)
16.7
(7.5 to 30.2)
20.0
(11.0 to 33.8)
29.7
(18.5 to 43.3)
44.4
(30.2 to 59.1)
13.9
(6.9 to 25.4)
28.6
(16.4 to 41.9)
25.7
(15.4 to 39.2)
At Week 2
24.3
(14.5 to 37.0)
30.6
(18.9 to 44.0)
42.9
(30.0 to 58.1)
48.6
(34.3 to 63.0)
61.1
(47.0 to 74.6)
25.0
(14.9 to 38.0)
45.7
(31.7 to 60.8)
37.1
(23.6 to 52.2)
At Week 3
21.6
(11.2 to 34.3)
38.9
(25.4 to 53.0)
48.6
(33.8 to 63.5)
59.5
(45.6 to 72.0)
58.3
(44.0 to 71.0)
33.3
(21.3 to 47.0)
51.4
(36.5 to 66.2)
57.1
(41.9 to 70.0)
At Week 4
35.1
(22.2 to 49.3)
38.9
(25.4 to 53.0)
51.4
(36.5 to 66.2)
62.2
(48.0 to 75.2)
58.3
(44.0 to 71.0)
30.6
(18.9 to 44.0)
60.0
(44.8 to 74.0)
60.0
(44.8 to 74.0)
At Week 6
40.5
(28.0 to 54.4)
41.7
(29.0 to 56.0)
51.4
(36.5 to 66.2)
56.8
(43.2 to 70.7)
61.1
(47.0 to 74.6)
30.6
(18.9 to 44.0)
60.0
(44.8 to 74.0)
60.0
(44.8 to 74.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5246
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.5
Confidence Interval (2-Sided) 90%
-14.7 to 16.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3906
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.8
Confidence Interval (2-Sided) 90%
-12.5 to 19.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1193
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.5
Confidence Interval (2-Sided) 90%
-3.2 to 30.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 28.2
Confidence Interval (2-Sided) 90%
8.8 to 45.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0777
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 14.7
Confidence Interval (2-Sided) 90%
-2.0 to 31.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1245
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.8
Confidence Interval (2-Sided) 90%
-4.3 to 28.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3322
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.2
Confidence Interval (2-Sided) 90%
-12.2 to 24.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0535
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.5
Confidence Interval (2-Sided) 90%
-0.3 to 36.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0159
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 24.3
Confidence Interval (2-Sided) 90%
4.5 to 41.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 36.8
Confidence Interval (2-Sided) 90%
15.4 to 54.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0386
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.7
Confidence Interval (2-Sided) 90%
1.5 to 38.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1485
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.1
Confidence Interval (2-Sided) 90%
-6.4 to 30.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0620
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.3
Confidence Interval (2-Sided) 90%
-0.8 to 34.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0089
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 26.9
Confidence Interval (2-Sided) 90%
6.5 to 44.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 37.8
Confidence Interval (2-Sided) 90%
17.5 to 54.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 36.7
Confidence Interval (2-Sided) 90%
15.4 to 54.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0711
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.1
Confidence Interval (2-Sided) 90%
-2.0 to 37.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0266
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 23.8
Confidence Interval (2-Sided) 90%
2.7 to 42.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4173
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.8
Confidence Interval (2-Sided) 90%
-15.3 to 23.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1096
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.3
Confidence Interval (2-Sided) 90%
-4.3 to 35.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.0
Confidence Interval (2-Sided) 90%
6.1 to 45.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0304
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 23.2
Confidence Interval (2-Sided) 90%
2.6 to 41.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.4
Confidence Interval (2-Sided) 90%
7.2 to 47.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.4
Confidence Interval (2-Sided) 90%
7.2 to 47.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4966
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.1
Confidence Interval (2-Sided) 90%
-18.4 to 20.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2753
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.9
Confidence Interval (2-Sided) 90%
-9.3 to 30.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1036
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.2
Confidence Interval (2-Sided) 90%
-4.2 to 35.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0457
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.6
Confidence Interval (2-Sided) 90%
0.4 to 39.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.4
Confidence Interval (2-Sided) 90%
7.2 to 47.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.4
Confidence Interval (2-Sided) 90%
7.2 to 47.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
Hide Description The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. NRI method: participants with missing values were considered to be non-responders.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Hide Arm/Group Description:
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Overall Number of Participants Analyzed 33 30 32 31 28 30 30 27
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
At Week 1
0.0
(0.0 to 8.2)
3.3
(0.4 to 14.0)
3.1
(0.3 to 13.1)
16.1
(8.1 to 29.7)
10.7
(4.0 to 23.8)
3.3
(0.4 to 14.0)
3.3
(0.4 to 14.0)
11.1
(4.2 to 24.8)
At Week 2
9.1
(3.4 to 20.2)
10.0
(3.7 to 22.1)
9.4
(3.5 to 20.7)
19.4
(8.8 to 32.7)
25.0
(13.9 to 40.0)
10.0
(3.7 to 22.1)
13.3
(5.9 to 27.9)
33.3
(20.4 to 50.0)
At Week 3
12.1
(5.4 to 25.1)
23.3
(12.9 to 37.6)
15.6
(7.8 to 28.7)
32.3
(18.7 to 48.2)
32.1
(19.7 to 47.3)
10.0
(3.7 to 22.1)
20.0
(9.1 to 33.9)
37.0
(22.1 to 54.7)
At Week 4
18.2
(8.2 to 31.3)
26.7
(14.0 to 41.6)
28.1
(17.0 to 43.3)
35.5
(21.3 to 51.8)
50.0
(33.3 to 66.7)
10.0
(3.7 to 22.1)
30.0
(18.2 to 45.5)
37.0
(22.1 to 54.7)
At Week 6
18.2
(8.2 to 31.3)
30.0
(18.2 to 45.5)
34.4
(20.7 to 50.0)
45.2
(29.7 to 60.1)
50.0
(33.3 to 66.7)
16.7
(8.3 to 30.8)
33.3
(19.3 to 49.2)
40.7
(24.8 to 58.3)
At Follow-up visit
9.1
(3.4 to 20.2)
30.0
(18.2 to 45.5)
21.9
(12.1 to 36.2)
19.4
(8.8 to 32.7)
21.4
(9.8 to 36.6)
20.0
(9.1 to 33.9)
20.0
(9.1 to 33.9)
7.4
(2.0 to 20.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2450
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.3
Confidence Interval (2-Sided) 90%
-5.4 to 14.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2575
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.1
Confidence Interval (2-Sided) 90%
-5.3 to 14.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0087
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.1
Confidence Interval (2-Sided) 90%
5.7 to 31.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0392
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.7
Confidence Interval (2-Sided) 90%
0.8 to 25.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-11.2 to 11.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 1: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1528
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.8
Confidence Interval (2-Sided) 90%
-4.9 to 22.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4989
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.9
Confidence Interval (2-Sided) 90%
-12.7 to 15.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5419
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.3
Confidence Interval (2-Sided) 90%
-13.6 to 14.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1362
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.3
Confidence Interval (2-Sided) 90%
-5.0 to 26.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0541
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 15.9
Confidence Interval (2-Sided) 90%
-0.4 to 33.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3945
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.3
Confidence Interval (2-Sided) 90%
-12.0 to 19.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 2: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0201
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 23.3
Confidence Interval (2-Sided) 90%
3.9 to 41.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1372
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.2
Confidence Interval (2-Sided) 90%
-5.4 to 28.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3924
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.5
Confidence Interval (2-Sided) 90%
-11.6 to 19.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0311
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.1
Confidence Interval (2-Sided) 90%
2.4 to 38.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0392
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.0
Confidence Interval (2-Sided) 90%
0.8 to 38.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1541
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.0
Confidence Interval (2-Sided) 90%
-6.2 to 26.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 3: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0091
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.0
Confidence Interval (2-Sided) 90%
6.8 to 45.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2835
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.5
Confidence Interval (2-Sided) 90%
-9.5 to 27.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2700
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.9
Confidence Interval (2-Sided) 90%
-8.7 to 27.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0662
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.3
Confidence Interval (2-Sided) 90%
-1.4 to 36.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0050
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 31.8
Confidence Interval (2-Sided) 90%
9.2 to 50.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0302
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.0
Confidence Interval (2-Sided) 90%
2.2 to 38.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 4: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0091
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.0
Confidence Interval (2-Sided) 90%
6.8 to 45.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1561
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.8
Confidence Interval (2-Sided) 90%
-6.5 to 30.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0753
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.2
Confidence Interval (2-Sided) 90%
-2.7 to 34.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0108
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.0
Confidence Interval (2-Sided) 90%
5.7 to 46.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0050
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 31.8
Confidence Interval (2-Sided) 90%
9.2 to 50.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0775
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 16.7
Confidence Interval (2-Sided) 90%
-2.9 to 35.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 6: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0243
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 24.1
Confidence Interval (2-Sided) 90%
3.4 to 43.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0234
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.9
Confidence Interval (2-Sided) 90%
3.5 to 38.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1134
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.8
Confidence Interval (2-Sided) 90%
-2.8 to 29.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1362
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.3
Confidence Interval (2-Sided) 90%
-5.0 to 26.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1029
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.3
Confidence Interval (2-Sided) 90%
-3.4 to 29.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-17.9 to 17.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At follow-up visit: Risk difference = difference in percentage of participants.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8972
Comments [Not Specified]
Method Chan and Zhang Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -12.6
Confidence Interval (2-Sided) 90%
-28.8 to 3.5
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
Hide Description 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.
Time Frame Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Arm/Group Title Vehicle Cream Once Daily (QD) PF-06700841 0.1% Cream QD PF-06700841 0.3% Cream QD PF-06700841 1.0% Cream QD PF-06700841 3.0% Cream QD Vehicle Cream Twice Daily (BID) PF-06700841 0.3% Cream BID PF-06700841 1.0% Cream BID
Hide Arm/Group Description:
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Overall Number of Participants Analyzed 34 36 33 35 34 34 36 36
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percent change
At Week 1 Number Analyzed 34 participants 36 participants 33 participants 35 participants 34 participants 34 participants 36 participants 36 participants
-2.4
(-12.2 to 7.4)
-2.9
(-12.5 to 6.8)
-16.2
(-26.2 to -6.2)
-19.9
(-29.6 to -10.2)
-23.0
(-32.8 to -13.1)
8.5
(-8.3 to 25.3)
-16.5
(-32.9 to -0.1)
-17.0
(-33.5 to -0.5)
At Week 2 Number Analyzed 34 participants 33 participants 33 participants 33 participants 32 participants 32 participants 33 participants 32 participants
-15.3
(-28.0 to -2.6)
-7.2
(-20.2 to 5.8)
-38.1
(-51.0 to -25.2)
-43.6
(-56.5 to -30.8)
-39.0
(-52.1 to -26.0)
-2.5
(-14.0 to 9.1)
-34.2
(-45.4 to -22.9)
-43.1
(-54.5 to -31.6)
At Week 3 Number Analyzed 28 participants 29 participants 32 participants 34 participants 31 participants 23 participants 30 participants 33 participants
-17.1
(-31.0 to -3.1)
-13.1
(-27.4 to 1.1)
-50.6
(-64.4 to -36.7)
-55.9
(-69.7 to -42.0)
-49.2
(-63.2 to -35.1)
-25.2
(-39.2 to -11.1)
-39.8
(-53.0 to -26.6)
-44.0
(-57.1 to -30.9)
At Week 4 Number Analyzed 30 participants 28 participants 33 participants 32 participants 32 participants 25 participants 32 participants 32 participants
-25.9
(-39.8 to -12.0)
-20.1
(-34.4 to -5.7)
-55.8
(-69.5 to -42.1)
-57.9
(-71.7 to -44.0)
-56.7
(-70.8 to -42.7)
-34.7
(-46.1 to -23.3)
-46.4
(-56.9 to -35.9)
-57.7
(-68.2 to -47.2)
At Week 6 Number Analyzed 29 participants 28 participants 31 participants 32 participants 31 participants 24 participants 32 participants 33 participants
-21.6
(-38.0 to -5.3)
-39.4
(-56.1 to -22.7)
-59.4
(-75.4 to -43.5)
-63.6
(-79.5 to -47.6)
-60.3
(-76.4 to -44.1)
-31.2
(-42.5 to -20.0)
-48.9
(-59.3 to -38.6)
-65.0
(-75.3 to -54.7)
At Follow-up visit Number Analyzed 29 participants 27 participants 32 participants 31 participants 26 participants 28 participants 30 participants 29 participants
-23.6
(-39.5 to -7.6)
-24.5
(-41.0 to -8.0)
-42.7
(-58.1 to -27.2)
-37.0
(-52.6 to -21.4)
-55.2
(-71.8 to -38.6)
-26.3
(-47.5 to -5.2)
-31.6
(-52.0 to -11.3)
-24.6
(-45.2 to -4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 1: Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4781
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.5
Confidence Interval (2-Sided) 90%
-14.2 to 13.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0522
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -13.8
Confidence Interval (2-Sided) 90%
-27.8 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0187
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -17.5
Confidence Interval (2-Sided) 90%
-31.4 to -3.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0080
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -20.6
Confidence Interval (2-Sided) 90%
-34.5 to -6.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0401
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -25.0
Confidence Interval (2-Sided) 90%
-48.6 to -1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0379
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -25.5
Confidence Interval (2-Sided) 90%
-49.2 to -1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 2: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7678
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 8.1
Confidence Interval (2-Sided) 90%
-10.1 to 26.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0193
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -22.8
Confidence Interval (2-Sided) 90%
-40.9 to -4.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 2:MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -28.3
Confidence Interval (2-Sided) 90%
-46.5 to -10.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0164
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -23.7
Confidence Interval (2-Sided) 90%
-42.0 to -5.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -31.7
Confidence Interval (2-Sided) 90%
-47.8 to -15.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -40.6
Confidence Interval (2-Sided) 90%
-57.0 to -24.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6269
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 3.9
Confidence Interval (2-Sided) 90%
-16.1 to 23.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -33.5
Confidence Interval (2-Sided) 90%
-53.1 to -13.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 1.0% Cream QD
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -38.8
Confidence Interval (2-Sided) 90%
-58.5 to -19.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 3.0% Cream QD
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -32.1
Confidence Interval (2-Sided) 90%
-51.9 to -12.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 0.3% Cream BID
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1054
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -14.6
Confidence Interval (2-Sided) 90%
-33.9 to 4.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Twice Daily (BID), PF-06700841 1.0% Cream BID
Comments At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0542
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -18.8
Confidence Interval (2-Sided) 90%
-38.1 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.1% Cream QD
Comments At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6847
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 5.8
Confidence Interval (2-Sided) 90%
-14.2 to 25.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vehicle Cream Once Daily (QD), PF-06700841 0.3% Cream QD
Comments At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -29.9