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A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

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ClinicalTrials.gov Identifier: NCT03539601
Recruitment Status : Terminated (This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.)
First Posted : May 29, 2018
Results First Posted : January 10, 2022
Last Update Posted : January 10, 2022
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: Crisaborole ointment, 2%
Drug: Hydrocortisone butyrate cream, 0.1%
Drug: Pimecrolimus cream, 1%
Drug: Crisaborole Vehicle
Enrollment 237
Recruitment Details At time of early termination, less than 40% of planned participants were treated across treatment groups. Number of participants enrolled up to early termination of study were insufficient to allow a meaningful inference and robust statistical analyses of data. As a result, all safety data was summarized with Cohort 1 and Cohort 2 combined for crisaborole and vehicle groups.
Pre-assignment Details This study was originally plan to conduct in 2 different cohorts for crisaborole and vehicle groups. Cohort 1 was planned for participants eligible for topical corticosteroid (TCS) therapy (hydrocortisone butyrate cream 0.1%), and Cohort 2 was planned for participants not eligible for TCS therapy but eligible for topical calcineurin inhibitor (TCI) therapy (pimecrolimus cream 1%).
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description Vehicle matched to crisaborole 2% ointment was applied topically bis in diem (BID - twice a day) to all treatable atopic dermatitis (AD) involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Period Title: Overall Study
Started 60 59 71 47
Treated 59 58 71 47
Completed 54 52 65 46
Not Completed 6 7 6 1
Reason Not Completed
Withdraw by parent/guardian             1             0             1             0
Adverse Event             0             2             0             0
Lost to Follow-up             2             4             5             0
Withdrawal by Subject             2             0             0             1
Randomized but not treated             1             1             0             0
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID Total
Hide Arm/Group Description Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Total of all reporting groups
Overall Number of Baseline Participants 59 58 71 47 235
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomized participants received at least 1 dose of investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 58 participants 71 participants 47 participants 235 participants
19.8  (18.22) 21.5  (19.12) 19.6  (16.28) 21.1  (18.20) 20.4  (17.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 71 participants 47 participants 235 participants
Female
35
  59.3%
35
  60.3%
43
  60.6%
26
  55.3%
139
  59.1%
Male
24
  40.7%
23
  39.7%
28
  39.4%
21
  44.7%
96
  40.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 71 participants 47 participants 235 participants
Hispanic or Latino
6
  10.2%
1
   1.7%
11
  15.5%
4
   8.5%
22
   9.4%
Not Hispanic or Latino
53
  89.8%
57
  98.3%
60
  84.5%
43
  91.5%
213
  90.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 71 participants 47 participants 235 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   3.4%
3
   5.2%
1
   1.4%
3
   6.4%
9
   3.8%
Native Hawaiian or Other Pacific Islander
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
Black or African American
17
  28.8%
14
  24.1%
23
  32.4%
6
  12.8%
60
  25.5%
White
38
  64.4%
38
  65.5%
44
  62.0%
37
  78.7%
157
  66.8%
More than one race
1
   1.7%
3
   5.2%
1
   1.4%
0
   0.0%
5
   2.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
   2.8%
1
   2.1%
3
   1.3%
1.Primary Outcome
Title Percent Change From Baseline in the Eczema Area and Severity Index (EASI) Total Score at Day 29
Hide Description EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and percent (%) body surface area (%BSA) affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck [h], upper limbs [u], trunk [t] [including axillae, groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) based upon %BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%), 6 (90 to 100%). Total EASI score (aged >=8 years) =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); for aged 2 to <8 years =0.2*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.3*Al*(El + Il + Exl + Ll). Total score ranges from 0.0 to 72.0, higher scores indicated greater AD severity.
Time Frame Baseline, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Arm/Group Title Vehicle: Participants 2-17 Years Crisaborole Ointment 2% BID: Participants 2-17 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants 2-17 Years Pimecrolimus Cream 1% BID: Participants 2-17 Years Vehicle: Participants >=18 Years Crisaborole Ointment 2% BID: Participants >=18 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants >=18 Years Pimecrolimus Cream 1% BID: Participants >=18 Years
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 31 31 36 29 17 19 29 14
Mean (Standard Deviation)
Unit of Measure: Percent change
-26.62  (46.283) -49.47  (34.195) -75.50  (30.305) -60.08  (31.877) -44.67  (49.267) -57.14  (48.345) -70.29  (32.097) -62.59  (28.317)
2.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Discontinuations Due to AEs and SAEs
Hide Description An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs are events between the first dose of study drug up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A SAE is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event.
Time Frame From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of the investigational product according to actual treatment received.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 59 58 71 47
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
18
  30.5%
25
  43.1%
12
  16.9%
24
  51.1%
SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Discontinuation due to AEs
0
   0.0%
3
   5.2%
0
   0.0%
0
   0.0%
Discontinuation due to SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Local Tolerability Adverse Events (AEs)
Hide Description Local tolerability AEs included application and instillation site reactions, application site discharge, application site erythema, application site exfoliation, application site pain, application site pruritus, application site swelling, dermatitis and eczema, dermatitis atopic, dermatitis contact, eczema, skin irritation, telangiectasia and related conditions, and urticarias.
Time Frame From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of the investigational product according to actual treatment received.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 59 58 71 47
Measure Type: Count of Participants
Unit of Measure: Participants
12
  20.3%
13
  22.4%
2
   2.8%
8
  17.0%
4.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Vital Signs
Hide Description Vital sign measurements included temperature, respiratory rate, pulse rate, and blood pressure. Temperature, respiratory rate, pulse rate, and blood pressure were taken in the seated or supine position, after the participant has been sitting or lying calmly for a minimum of 5 minutes (when possible for younger children). Position of recording was consistent within participant through-out the study.
Time Frame Screening up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of the investigational product according to actual treatment received.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 59 58 71 47
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Hide Description Hematology parameters included with criteria greater than (>) 1.2*upper limit of normal (ULN): leukocytes (10^3 per cubic millimeter [10^3/mm^3]), lymphocytes (10^3/mm^3), lymphocytes/leukocytes (%), neutrophils (10^3/mm^3), neutrophils/leukocytes (%), basophils/leukocytes (%), eosinophils (10^3/mm^3), eosinophils/leukocytes (%), monocytes (10^3/mm^3), monocytes/leukocytes (%). Clinical chemistry included parameters: aspartate aminotransferase (units per liter [U/L]) (>3.0* ULN), alanine aminotransferase (U/L) (>3.0* ULN), alkaline phosphatase (U/L) (>3.0* ULN), creatinine (milligram per deciliter [mg/dL]) (>1.3* ULN), potassium (milliequivalent per liter [mEq/L]) (>1.1* ULN), bicarbonate (mEq/L) (>1.1* ULN).
Time Frame Screening up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of the investigational product according to actual treatment received.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 59 58 71 47
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
6.Secondary Outcome
Title Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 8, 15 and 22
Hide Description EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and %BSA affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck [h], upper limbs [u], trunk [t] [including axillae, groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score(A) based upon %BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%), 6 (90 to 100%). Total EASI score (aged >=8 years) =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); for aged 2 to <8 years =0.2*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.3*Al*(El + Il + Exl + Ll). Total score ranges from 0.0 to 72.0, higher scores indicated greater AD severity.
Time Frame Baseline, Day 8, 15 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of investigational product. Here, 'number analyzed' signifies number of participants evaluable for each specified row.
Arm/Group Title Vehicle: Participants 2-17 Years Crisaborole Ointment 2% BID: Participants 2-17 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants 2-17 Years Pimecrolimus Cream 1% BID: Participants 2-17 Years Vehicle: Participants >=18 Years Crisaborole Ointment 2% BID: Participants >=18 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants >=18 Years Pimecrolimus Cream 1% BID: Participants >=18 Years
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 38 37 38 30 21 21 32 17
Mean (Standard Deviation)
Unit of Measure: Percent change
Percent Change at Day 8 Number Analyzed 37 participants 33 participants 33 participants 29 participants 19 participants 21 participants 27 participants 16 participants
-17.88  (36.705) -26.79  (39.280) -45.59  (28.103) -34.20  (25.972) -14.77  (26.308) -29.83  (44.599) -42.48  (27.843) -18.75  (39.016)
Percent Change at Day 15 Number Analyzed 33 participants 33 participants 37 participants 30 participants 15 participants 20 participants 27 participants 14 participants
-25.77  (35.658) -36.72  (36.625) -58.96  (32.617) -42.75  (31.854) -25.93  (31.690) -48.42  (33.458) -56.29  (32.186) -37.18  (50.487)
Percent Change at Day 22 Number Analyzed 32 participants 31 participants 35 participants 26 participants 18 participants 19 participants 27 participants 15 participants
-25.07  (49.326) -38.87  (32.624) -69.09  (31.528) -59.86  (24.835) -34.43  (30.587) -56.05  (38.934) -61.82  (27.894) -42.25  (40.192)
7.Secondary Outcome
Title Number of Participants Who Achieved Success in the Investigator's Static Global Assessment (ISGA) (ISGA Score of Clear [0] or Almost Clear [1] With At-least a 2-Grade Improvement From Baseline) at Day 8, 15, 22 and 29
Hide Description ISGA is a five point global assessment scale of AD severity, used to characterize participants' overall disease severity across all treatable AD lesions (excluding the scalp). ISGA score ranged from 0 to 4: where 0= clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity of AD.
Time Frame Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of investigational product.
Arm/Group Title Vehicle: Participants 2-17 Years Crisaborole Ointment 2% BID: Participants 2-17 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants 2-17 Years Pimecrolimus Cream 1% BID: Participants 2-17 Years Vehicle: Participants >=18 Years Crisaborole Ointment 2% BID: Participants >=18 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants >=18 Years Pimecrolimus Cream 1% BID: Participants >=18 Years
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 38 37 39 30 21 21 32 17
Measure Type: Count of Participants
Unit of Measure: Participants
Day 8
2
   5.3%
0
   0.0%
2
   5.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 15
1
   2.6%
3
   8.1%
8
  20.5%
2
   6.7%
0
   0.0%
0
   0.0%
6
  18.8%
1
   5.9%
Day 22
2
   5.3%
2
   5.4%
11
  28.2%
5
  16.7%
1
   4.8%
3
  14.3%
9
  28.1%
1
   5.9%
Day 29
2
   5.3%
5
  13.5%
20
  51.3%
7
  23.3%
3
  14.3%
6
  28.6%
13
  40.6%
2
  11.8%
8.Secondary Outcome
Title Number of Participants Who Achieved Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 8, 15, 22 and 29
Hide Description ISGA is a five point global assessment scale of AD severity, used to characterize participants' overall disease severity across all treatable AD lesions (excluding the scalp). ISGA score ranged from 0 to 4: where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity of AD.
Time Frame Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of investigational product.
Arm/Group Title Vehicle: Participants 2-17 Years Crisaborole Ointment 2% BID: Participants 2-17 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants 2-17 Years Pimecrolimus Cream 1% BID: Participants 2-17 Years Vehicle: Participants >=18 Years Crisaborole Ointment 2% BID: Participants >=18 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants >=18 Years Pimecrolimus Cream 1% BID: Participants >=18 Years
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 38 37 39 30 21 21 32 17
Measure Type: Count of Participants
Unit of Measure: Participants
Day 8
6
  15.8%
3
   8.1%
12
  30.8%
5
  16.7%
0
   0.0%
4
  19.0%
4
  12.5%
2
  11.8%
Day 15
6
  15.8%
7
  18.9%
19
  48.7%
9
  30.0%
1
   4.8%
3
  14.3%
11
  34.4%
5
  29.4%
Day 22
6
  15.8%
8
  21.6%
19
  48.7%
9
  30.0%
1
   4.8%
8
  38.1%
13
  40.6%
5
  29.4%
Day 29
6
  15.8%
10
  27.0%
27
  69.2%
13
  43.3%
4
  19.0%
9
  42.9%
20
  62.5%
7
  41.2%
9.Secondary Outcome
Title Number of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 8, 15, 22 and 29
Hide Description EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and %BSA affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck [h], upper limbs [u], trunk [t] [including axillae, groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score(A) based upon %BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%), 6 (90 to 100%). Total EASI score (aged >=8 years) =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); for aged 2 to <8 years =0.2*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.3*Al*(El + Il + Exl + Ll). Total score ranges from 0.0 to 72.0, higher scores indicated greater AD severity.
Time Frame Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 59 58 70 47
Measure Type: Count of Participants
Unit of Measure: Participants
Day 8
2
   3.4%
7
  12.1%
9
  12.9%
2
   4.3%
Day 15
4
   6.8%
10
  17.2%
25
  35.7%
8
  17.0%
Day 22
8
  13.6%
13
  22.4%
29
  41.4%
11
  23.4%
Day 29
9
  15.3%
17
  29.3%
40
  57.1%
17
  36.2%
10.Secondary Outcome
Title Time to First Improvement From Baseline in Eczema Area and Severity Index (EASI) Total Score of Greater Than or Equal to (>=) 75%
Hide Description EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and %BSA affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck [h], upper limbs [u], trunk [t] [including axillae, groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score(A) based upon %BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%), 6 (90 to 100%). Total EASI score (aged >=8 years) =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); for aged 2 to <8 years =0.2*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.3*Al*(El + Il + Exl + Ll). Total score ranges from 0.0 to 72.0, higher scores indicated greater AD severity.
Time Frame Baseline up to Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 59 58 70 47
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
43.0 [2] 
(28.0 to NA)
23.0
(16.0 to 34.0)
32.0 [2] 
(27.0 to NA)
[1]
Median and 95% CI could not be estimated because there were insufficient number of participants with event.
[2]
Upper limit for 95% CI could not be estimated because there were insufficient number of participants with events to calculate the full 95% CI.
11.Secondary Outcome
Title Change From Baseline in Percent Body Surface Area (%BSA) at Day 8, 15, 22 and 29
Hide Description Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae) and lower limbs (including buttocks) excluding scalp. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand in a closed position) fitting in affected area of a body region was estimated. Maximum number of handprints were: 10 for head, neck (20 for <8 years age), 20 for upper limbs, 30 for trunk, 40 for lower limbs (30 for <8 years age). Surface area (SA) of body region equivalent to 1 handprint: 10% for head, neck (5% for <8 years age), 5% for upper limbs, 3.33% for trunk, 2.5% for lower limbs (3.33% for <8 years age). Overall %BSA for a body region = total number of handprints in a body region * % SA equivalent to 1 handprint. % BSA for an individual: mean of % BSA of all 4 body regions, range =0-100%, higher values = greater AD severity.
Time Frame Baseline, Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of investigational product. Here 'number analyzed' signifies number of participants evaluable for each specified row.
Arm/Group Title Vehicle: Participants 2-17 Years Crisaborole Ointment 2% BID: Participants 2-17 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants 2-17 Years Pimecrolimus Cream 1% BID: Participants 2-17 Years Vehicle: Participants >=18 Years Crisaborole Ointment 2% BID: Participants >=18 Years Hydrocortisone Butyrate Cream 0.1% BID: Participants >=18 Years Pimecrolimus Cream 1% BID: Participants >=18 Years
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 38 37 39 30 21 21 32 17
Mean (Standard Deviation)
Unit of Measure: Percent BSA
Change at Day 8 Number Analyzed 37 participants 33 participants 33 participants 29 participants 19 participants 21 participants 27 participants 16 participants
-2.04  (7.533) -2.63  (11.920) -5.25  (8.346) -2.84  (5.296) -1.39  (4.417) -4.09  (6.397) -2.74  (2.718) -1.44  (5.600)
Change at Day 15 Number Analyzed 33 participants 33 participants 37 participants 30 participants 15 participants 20 participants 27 participants 14 participants
-2.38  (8.566) -4.32  (12.620) -7.40  (9.515) -3.72  (4.401) -3.73  (5.895) -4.63  (7.211) -5.00  (5.189) -3.56  (5.750)
Change at Day 22 Number Analyzed 32 participants 31 participants 35 participants 26 participants 18 participants 19 participants 27 participants 15 participants
-2.23  (12.321) -7.14  (10.123) -8.54  (11.226) -6.52  (9.883) -4.19  (5.464) -5.98  (7.852) -4.91  (5.190) -4.17  (5.588)
Change at Day 29 Number Analyzed 31 participants 31 participants 36 participants 29 participants 17 participants 19 participants 29 participants 14 participants
-3.38  (9.974) -9.95  (11.324) -9.63  (12.309) -7.30  (10.774) -6.76  (8.089) -7.18  (8.183) -7.18  (5.971) -6.86  (8.172)
12.Secondary Outcome
Title Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Participants Aged Greater Than or Equal to (>=) 12 Years at Day 8, 15, 22 and 29
Hide Description The severity of itch (pruritus) due to AD was assessed using the peak pruritus NRS for participants aged >=12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline, Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants aged >=12 years from FAS, and FAS included all randomized participants who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 33 33 45 28
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Day 8 Number Analyzed 30 participants 30 participants 43 participants 26 participants
-0.67  (1.254) -1.01  (1.145) -2.24  (2.065) -0.29  (1.225)
Change at Day 15 Number Analyzed 29 participants 32 participants 43 participants 25 participants
-0.97  (1.778) -1.08  (1.419) -3.21  (2.598) -1.35  (1.707)
Change at Day 22 Number Analyzed 27 participants 30 participants 42 participants 24 participants
-0.98  (1.887) -1.28  (1.642) -3.83  (2.554) -1.66  (1.759)
Change at Day 29 Number Analyzed 27 participants 29 participants 42 participants 24 participants
-1.30  (2.157) -1.65  (1.996) -4.02  (2.734) -1.67  (1.952)
13.Secondary Outcome
Title Change From Baseline in Participant Reported Itch Severity Scale in Participants Aged 6-11 Years at Day 8, 15, 22 and 29
Hide Description The severity of itch (pruritus) due to AD was assessed using the five-category participant reported itch severity scale for participants aged 6-11 years. Participants at specified time points were asked to "circle the face that shows how itchy your skin has been today". The scale ranged from 0 to 4, where 0= no itch and 4= very itch. Higher scores indicated worse itch.
Time Frame Baseline, Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized as per SAP which was revised prior to the analyses and which reflect limitations related to reduced sample size (39% enrollment) of early terminated study. Smaller than originally planned sample size was insufficient to allow robust statistical analyses. Pruritus related PRO endpoints used different instruments in each of 3 age groups. As a result, subdividing population based on age group renders smaller sample size in pediatric groups, therefore data was not summarized.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years at Day 8, 15, 22 and 29
Hide Description The severity of itch (pruritus) due to AD was assessed using the participant reported itch severity scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline, Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized as per SAP which was revised prior to the analyses and which reflect limitations related to reduced sample size (39% enrollment) of early terminated study. Smaller than originally planned sample size was insufficient to allow robust statistical analyses. Pruritus related PRO endpoints used different instruments in each of 3 age groups. As a result, subdividing population based on age group renders smaller sample size in pediatric groups, therefore data was not summarized.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Time to Greater Than or Equal to (>=2) Point Improvement From Baseline in Peak Pruritus Numeric Rating Scale (NRS) in Participants Aged Greater Than (>) 12 Years
Hide Description The severity of itch (pruritus) due to AD was assessed using the peak pruritus NRS for participants aged >12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized as per SAP which was revised prior to the analyses and which reflected limitations related to reduced sample size (only 39% enrollment) of early terminated study. Smaller than originally planned sample size was insufficient to allow robust statistical analyses. Summarizing further by Time to >2 Point Improvement will not provide additional useful information due to smaller than planned sample size as a result of study early termination.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Time to >= 3 Point Improvement From Baseline in Peak Pruritus Numeric Rating Scale (NRS) in Participants Aged Greater Than (>)12 Years
Hide Description The severity of itch (pruritus) due to AD was assessed using the Peak Pruritus NRS for participants aged >12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized as per SAP which was revised prior to the analyses and which reflected limitations related to reduced sample size (only 39% enrollment) of early terminated study. Smaller than originally planned sample size was insufficient to allow robust statistical analyses. Summarizing further by Time to >3 Point Improvement will not provide additional useful information due to smaller than planned sample size as a result of study early termination.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Time >=2 Point to Improvement From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years
Hide Description The severity of itch (pruritus) due to AD was assessed using the patient reported itch severity scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized as per SAP which was revised prior to the analyses and which reflect limitations related to reduced sample size (39% enrollment) of early terminated study. Smaller than originally planned sample size was insufficient to allow robust statistical analyses. Pruritus related PRO endpoints used different instruments in each of 3 age groups. As a result, subdividing population based on age group renders smaller sample size in pediatric groups, therefore data was not summarized.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Time to >=3 Point Improvement From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years
Hide Description The severity of itch (pruritus) due to AD was assessed using the Patient Reported Itch Severity Scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized as per SAP which was revised prior to the analyses and which reflect limitations related to reduced sample size (39% enrollment) of early terminated study. Smaller than originally planned sample size was insufficient to allow robust statistical analyses. Pruritus related PRO endpoints used different instruments in each of 3 age groups. As a result, subdividing population based on age group renders smaller sample size in pediatric groups, therefore data was not summarized.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Number of Participants Who Achieved >=2 Point Improvement From Baseline in Peak Pruritus Numeric Rating Scale (NRS) in Participants Aged Greater Than or Equal to (>=) 12 Years at Day 8, 15, 22 and 29
Hide Description The severity of itch (pruritus) due to AD was assessed using the peak pruritus NRS for participants aged >=12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants aged >=12 years from FAS, and FAS included all randomized participants who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 31 32 42 26
Measure Type: Count of Participants
Unit of Measure: Participants
Day 8
3
   9.7%
7
  21.9%
21
  50.0%
1
   3.8%
Day 15
9
  29.0%
8
  25.0%
31
  73.8%
7
  26.9%
Day 22
9
  29.0%
7
  21.9%
32
  76.2%
9
  34.6%
Day 29
10
  32.3%
9
  28.1%
32
  76.2%
9
  34.6%
20.Secondary Outcome
Title Number of Participants Who Achieved >=3 Point Improvement From Baseline in Peak Pruritus Numeric Rating Scale (NRS) in Participants Aged Greater Than or Equal to (>=) 12 Years at Day 8, 15, 22 and 29
Hide Description The severity of itch (pruritus) due to AD was assessed using the Peak Pruritus NRS for participants aged >=12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants aged >=12 years from FAS, and FAS included all randomized participants who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 29 29 40 26
Measure Type: Count of Participants
Unit of Measure: Participants
Day 8
2
   6.9%
1
   3.4%
11
  27.5%
0
   0.0%
Day 15
5
  17.2%
5
  17.2%
21
  52.5%
3
  11.5%
Day 22
4
  13.8%
4
  13.8%
25
  62.5%
4
  15.4%
Day 29
6
  20.7%
6
  20.7%
24
  60.0%
6
  23.1%
21.Secondary Outcome
Title Number of Participants Who Achieved Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years at Day 8, 15, 22 and 29
Hide Description The severity of itch (pruritus) due to AD was assessed using the Patient Reported Itch Severity Scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized as per SAP which was revised prior to the analyses and which reflect limitations related to reduced sample size (39% enrollment) of early terminated study. Smaller than originally planned sample size was insufficient to allow robust statistical analyses. Pruritus related PRO endpoints used different instruments in each of 3 age groups. As a result, subdividing population based on age group renders smaller sample size in pediatric groups, therefore data was not summarized.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Number of Participants Who Achieved Greater Than or Equal to (>=) 3 Point Improvement From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years at Day 8, 15, 22 and 29
Hide Description The severity of itch (pruritus) due to AD was assessed using the Patient Reported Itch Severity Scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized as per SAP which was revised prior to the analyses and which reflect limitations related to reduced sample size (39% enrollment) of early terminated study. Smaller than originally planned sample size was insufficient to allow robust statistical analyses. Pruritus related PRO endpoints used different instruments in each of 3 age groups. As a result, subdividing population based on age group renders smaller sample size in pediatric groups, therefore data was not summarized.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) in Participants Greater Than or Equal to (>=) 16 Years at Day 8, 15, 22 and 29
Hide Description DLQI is a 10-item questionnaire that measures the impact of skin disease on participants aged >=16 years. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participant.
Time Frame Baseline, Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants aged >=16 years from FAS, and FAS included all randomized participants who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable for each specified row.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 23 26 32 23
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Day 8 Number Analyzed 20 participants 23 participants 27 participants 19 participants
-1.9  (5.53) -3.8  (3.45) -5.1  (4.98) -1.4  (2.99)
Change at Day 15 Number Analyzed 16 participants 23 participants 26 participants 17 participants
-3.4  (3.72) -3.5  (2.92) -6.8  (5.94) -2.9  (2.63)
Change at Day 22 Number Analyzed 18 participants 20 participants 25 participants 18 participants
-2.8  (4.12) -3.4  (4.73) -6.9  (6.37) -3.4  (3.88)
Change at Day 29 Number Analyzed 18 participants 19 participants 28 participants 17 participants
-4.9  (5.60) -3.9  (4.76) -7.0  (6.69) -4.1  (3.76)
24.Secondary Outcome
Title Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants Aged 4-15 Years at Day 8, 15, 22 and 29
Hide Description The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children's (aged 4 to 15 years) quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The CDLQI total score was the sum of individual scores of question 1-10 and ranged from 0 (not at all) to 30 (very much): 0-1 = no effect on the child's life; 2-6 = small effect; 7-12 = moderate effect; 13-18 = very large effect; 19-30 = extremely large effect. Higher scores indicated more impact on quality of life of children.
Time Frame Baseline, Day 8, 15, 22 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants aged 4 to 15 years from FAS, and FAS included all randomized participants who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and 'number analyzed' = participants evaluable for each specified row.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description:
Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 27 26 30 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Day 8 Number Analyzed 27 participants 22 participants 25 participants 15 participants
-0.2  (3.42) -2.1  (4.49) -5.4  (6.14) -1.7  (4.03)
Change at Day 15 Number Analyzed 22 participants 24 participants 29 participants 17 participants
-2.0  (4.49) -3.1  (5.13) -5.5  (6.32) -1.6  (4.66)
Change at Day 22 Number Analyzed 21 participants 21 participants 27 participants 13 participants
-2.7  (3.04) -2.6  (5.81) -4.9  (7.89) -2.5  (3.15)
Change at Day 29 Number Analyzed 20 participants 21 participants 28 participants 16 participants
-3.1  (2.73) -3.4  (4.85) -6.4  (5.49) -3.4  (3.52)
25.Secondary Outcome
Title Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) in Participants Aged 2-17 Years at Day 8, 15, 22 and 29
Hide Description The DFI was a 10-item disease questionnaire that measures the impact of having a child (aged 2-17 years) with AD on family quality of life. It was completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question was scored on a 4-point scale ranging from 0 (not at all) to 30 (very much): where higher scores indicated worst quality of life of family. The DFI total score was the sum of individual scores of the 10 questions and ranged from 0 (no impact on life of family) to 30 (maximum effect on life of family), where higher DFI scores indicated maximum effect on life of family.
Time Frame Baseline, Day 8, 15, 22 and 29
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Hide Analysis Population Description
Analysis was performed on all participants aged 2 to 17 years from FAS, and FAS included all randomized participants who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and 'number analyzed' = participants evaluable for each specified row.
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
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Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
Overall Number of Participants Analyzed 38 37 39 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Day 8 Number Analyzed 37 participants 32 participants 33 participants 28 participants
-1.2  (6.43) -2.3  (5.16) -5.6  (5.61) -2.8  (6.79)
Change at Day 15 Number Analyzed 32 participants 31 participants 37 participants 30 participants
-1.1  (6.77) -2.3  (4.71) -5.5  (6.82) -3.2  (5.94)
Change at Day 22 Number Analyzed 31 participants 29 participants 34 participants 26 participants
-2.5  (4.84) -3.1  (5.24) -5.3  (6.92) -4.5  (5.93)
Change at Day 29 Number Analyzed 30 participants 28 participants 35 participants 29 participants
-1.8  (5.26) -3.6  (4.40) -6.4  (5.61) -4.8  (5.61)
Time Frame Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days)
Adverse Event Reporting Description Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who received at least 1 dose of the investigational product according to actual treatment received.
 
Arm/Group Title Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Hide Arm/Group Description Vehicle matched to crisaborole 2% ointment was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Crisaborole ointment 2% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Hydrocortisone butyrate cream 0.1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60. Pimecrolimus cream 1% was applied topically BID to all treatable AD involved areas (excluding the scalp) identified at Baseline (Day 1) through Day 28. End of treatment visit was scheduled on Day 29. Participants were followed-up for at least 28 days after last dose, maximum up to Day 60.
All-Cause Mortality
Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/58 (0.00%)   0/71 (0.00%)   0/47 (0.00%) 
Hide Serious Adverse Events
Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/58 (0.00%)   0/71 (0.00%)   0/47 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vehicle Crisaborole Ointment 2% BID Hydrocortisone Butyrate Cream 0.1% BID Pimecrolimus Cream 1% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/59 (16.95%)   18/58 (31.03%)   4/71 (5.63%)   16/47 (34.04%) 
General disorders         
Application site pain * 1  1/59 (1.69%)  8/58 (13.79%)  0/71 (0.00%)  2/47 (4.26%) 
Infections and infestations         
Nasopharyngitis * 1  2/59 (3.39%)  3/58 (5.17%)  0/71 (0.00%)  3/47 (6.38%) 
Rhinitis * 1  0/59 (0.00%)  2/58 (3.45%)  1/71 (1.41%)  3/47 (6.38%) 
Nervous system disorders         
Headache * 1  1/59 (1.69%)  3/58 (5.17%)  2/71 (2.82%)  2/47 (4.26%) 
Skin and subcutaneous tissue disorders         
Dermatitis atopic * 1  7/59 (11.86%)  4/58 (6.90%)  2/71 (2.82%)  7/47 (14.89%) 
Eczema * 1  0/59 (0.00%)  3/58 (5.17%)  0/71 (0.00%)  1/47 (2.13%) 
1
Term from vocabulary, MedDRA 23.1
*
Indicates events were collected by non-systematic assessment
Study was terminated early by sponsor. Decision was not due to safety/efficacy concerns, but was related to business, portfolio reprioritization. Sub-study planned as per Amendment 3 was not initiated, as sub study site setup didn't complete prior to study termination.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 18007181021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03539601    
Other Study ID Numbers: C3291037
2018-001043-31 ( EudraCT Number )
First Submitted: May 16, 2018
First Posted: May 29, 2018
Results First Submitted: December 8, 2021
Results First Posted: January 10, 2022
Last Update Posted: January 10, 2022