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A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03260595
Recruitment Status : Completed
First Posted : August 24, 2017
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Healthy
Atopic Dermatitis
Interventions Drug: Crisaborole ointment 2%
Drug: Vehicle
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: Crisaborole Ointment 2% and Vehicle Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle
Hide Arm/Group Description Crisaborole ointment 2 percent (%) and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator. Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is atopic dermatitis [AD]-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant’s total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Period Title: Overall Study
Started 20 10 2
Completed 20 10 2
Not Completed 0 0 0
Arm/Group Title Cohort 1: Crisaborole Ointment 2% and Vehicle Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle Total
Hide Arm/Group Description Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator. Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant’s total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. Total of all reporting groups
Overall Number of Baseline Participants 20 10 2 32
Hide Baseline Analysis Population Description
Safety analysis population included all participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 10 participants 2 participants 32 participants
26.2  (5.66) 35.0  (11.28) 23.5  (4.95) 28.8  (8.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 2 participants 32 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
10
 100.0%
2
 100.0%
32
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 2 participants 32 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
20
 100.0%
10
 100.0%
2
 100.0%
32
 100.0%
Unknown or Not Reported
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 20 participants 10 participants 2 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
20
 100.0%
10
 100.0%
2
 100.0%
32
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Cohort 1: Skin Irritation Index
Hide Description The skin irritation index is a common measure of skin irritation potential (safety criteria) of investigational product and derived using skin irritation scores. Individual skin irritation score ranges from 0-4, where 0 = no reaction, 0.5 = mild erythema, 1 = erythema, 2 = erythema with edema and papula, 3 = erythema with edema, papula and small water blister, 4 = large water blister, higher score indicates more skin irritation. For each investigational product, the skin irritation index was calculated as the sum of the maximum individual skin irritation scores divided by the number of evaluable participants and multiplied by 100, which ranged from 0 to 400; where, lower score indicated less skin irritation and higher score indicated more skin irritation.
Time Frame Day 3 to 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 2, as pre-specified in protocol.
Arm/Group Title Cohort 1: Crisaborole Ointment 2% and Vehicle
Hide Arm/Group Description:
Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: scores on a scale
Crisaborole ointment 2% 40.0
Vehicle 5.0
2.Primary Outcome
Title Cohort 2: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 36) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.
Time Frame Baseline up to Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least one dose of study medication.
Arm/Group Title Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant’s total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 10 2
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
9
  90.0%
2
 100.0%
SAEs
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Cohort 2: Number of Participants With Clinically Significant Vital Signs Abnormalities
Hide Description Vital signs included pulse rate and blood pressure. Clinical significance of vital signs was determined at the investigator's discretion.
Time Frame Baseline up to end of treatment (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant’s total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 10 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Cohort 2: Number of Participants With Laboratory Tests Abnormalities
Hide Description Laboratory tests abnormalities included: hematology (haemoglobin[Hb], haematocrit and erythrocytes<0.8*lower limit of normal[LLN]; erythrocyte mean corpuscular volume, erythrocyte mean corpuscular Hb and erythrocyte mean corpuscular Hb concentration <0.9*LLN and >1.1*upper limit of normal[ULN]; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes/leukocytes[%], neutrophils/leukocytes[%] <0.8*LLN and >1.2*ULN; basophils/leukocytes[%], eosinophils/leukocytes[%], monocytes/leukocytes[% ]>1.2*ULN); clinical chemistry(bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase>3.0*ULN; protein and albumin<0.8*LLN and >1.2*ULN; urea nitrogen and creatinine >1.3*ULN; urate>1.2*ULN; sodium <0.95*LLN and >1.05*ULN; potassium, chloride and calcium <0.9*LLN and >1.1*ULN; fasting glucose <0.6*LLN and >1.5*ULN); and urinalysis (pH <4.5 and >8; glucose, ketones, protein, Hb, urobilinogen, bilirubin, nitrite and leukocyte esterase >=1).
Time Frame Baseline up to end of treatment (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant’s total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 10 2
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
1
  50.0%
5.Primary Outcome
Title Cohort 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Hide Description Criteria for clinically significant ECG abnormalities included: QT interval >=500 milliseconds (msec); QT interval corrected using the Fridericia’s formula (QTcF) >=450 msec to <480 msec, >=480 msec and >=500 msec; increase from baseline in QTcF interval >=30 msec to <60 msec and >=60 msec.
Time Frame Baseline up to end of treatment (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant’s total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 10 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Cohort 1: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 29) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least one dose of study medication.
Arm/Group Title Cohort 1: Crisaborole Ointment 2% and Vehicle
Hide Arm/Group Description:
Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
0
   0.0%
SAEs
0
   0.0%
7.Secondary Outcome
Title Cohort 2: Maximum Observed Plasma Concentration (Cmax) of Crisaborole and Its Identified Main Oxidative Metabolites
Hide Description AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
Time Frame Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2%
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
Crisaborole: Day 1
163.7
(71%)
Crisaborole: Day 8
164.9
(56%)
AN7602: Day 1
94.97
(75%)
AN7602: Day 8
68.83
(59%)
AN8323: Day 1
3064
(97%)
AN8323: Day 8
8080
(71%)
8.Secondary Outcome
Title Cohort 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crisaborole and Its Metabolites
Hide Description AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
Time Frame Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2%
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: hours
Crisaborole: Day 1
3.000
(3.00 to 3.00)
Crisaborole: Day 8
3.000
(3.00 to 3.00)
AN7602: Day 1
3.000
(3.00 to 3.00)
AN7602: Day 8
3.000
(3.00 to 3.00)
AN8323: Day 1
3.000
(3.00 to 12.0)
AN8323: Day 8
3.000
(3.00 to 12.0)
9.Secondary Outcome
Title Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Measurable Concentration (AUClast) of Crisaborole and Its Identified Main Oxidative Metabolites
Hide Description AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
Time Frame Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2%
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours*nanograms per milliliter(hr*ng/mL)
Crisaborole: Day 1
1171
(60%)
Crisaborole: Day 8
1527
(48%)
AN7602: Day 1
601.9
(60%)
AN7602: Day 8
565.5
(44%)
AN8323: Day 1
57560
(84%)
AN8323: Day 8
169100
(68%)
10.Secondary Outcome
Title Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hours Post-Dose (AUC24) of Crisaborole and Its Identified Main Oxidative Metabolites (AN7602 and AN8323)
Hide Description AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
Time Frame Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2%
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ng/mL
Crisaborole: Day 1
1171
(60%)
Crisaborole: Day 8
1527
(48%)
AN7602: Day 1
601.9
(60%)
AN7602: Day 8
565.5
(44%)
AN8323: Day 1
57560
(84%)
AN8323: Day 8
169100
(68%)
11.Secondary Outcome
Title Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Tau (12 Hours Dosing Interval) (AUCtau) of Crisaborole and Its Identified Main Oxidative Metabolites
Hide Description AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. AUC tau was defined as area under the plasma concentration-time curve from time 0 to time tau, the dosing interval, where tau =12 hours.
Time Frame Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2%
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ng/mL
Crisaborole: Day 1
928.9
(65%)
Crisaborole: Day 8
1123
(51%)
AN7602: Day 1
500.4
(66%)
AN7602: Day 8
434.9
(50%)
AN8323: Day 1
29360
(92%)
AN8323: Day 8
90360
(68%)
12.Secondary Outcome
Title Cohort 2: Accumulation Ratio for Cmax (Rac [Cmax]) of Crisaborole and Its Identified Main Oxidative Metabolites
Hide Description AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for Cmax (Rac, Cmax) was calculated as Cmax on Day 8 divided by Cmax on Day 1. Cmax was the maximum plasma concentration of Crisaborole and its identified main oxidative metabolites.
Time Frame Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2%
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
Crisaborole
1.007
(32%)
AN7602
0.7247
(24%)
AN8323
2.638
(52%)
13.Secondary Outcome
Title Cohort 2: Accumulation Ratio for AUCtau (Rac [AUCtau]) of Crisaborole and Its Identified Main Oxidative Metabolites
Hide Description AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 8 divided by AUCtau on Day 1. Dosing interval = 12 hours.
Time Frame Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.
Arm/Group Title Cohort 2: Crisaborole Ointment 2%
Hide Arm/Group Description:
Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
Crisaborole
1.209
(25%)
AN7602
0.8688
(19%)
AN8323
3.080
(48%)
Time Frame Baseline up to Day 29 for Cohort 1 and Day 36 for Cohort 2
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: Crisaborole Ointment 2% and Vehicle Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle
Hide Arm/Group Description Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator. Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant’s total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant’s total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator.
All-Cause Mortality
Cohort 1: Crisaborole Ointment 2% and Vehicle Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/10 (0.00%)   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Crisaborole Ointment 2% and Vehicle Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/10 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: Crisaborole Ointment 2% and Vehicle Cohort 2: Crisaborole Ointment 2% Cohort 2: Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   9/10 (90.00%)   2/2 (100.00%) 
Eye disorders       
Eyelid oedema * 1  0/20 (0.00%)  1/10 (10.00%)  0/2 (0.00%) 
General disorders       
Application site coldness * 1  0/20 (0.00%)  1/10 (10.00%)  1/2 (50.00%) 
Application site irritation * 1  0/20 (0.00%)  7/10 (70.00%)  1/2 (50.00%) 
Application site pain * 1  0/20 (0.00%)  4/10 (40.00%)  1/2 (50.00%) 
Application site pruritus * 1  0/20 (0.00%)  0/10 (0.00%)  1/2 (50.00%) 
Infections and infestations       
Nasopharyngitis * 1  0/20 (0.00%)  0/10 (0.00%)  1/2 (50.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis atopic * 1  0/20 (0.00%)  0/10 (0.00%)  1/2 (50.00%) 
1
Term from vocabulary, MedDRA v20.1
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03260595     History of Changes
Other Study ID Numbers: C3291029
First Submitted: August 9, 2017
First Posted: August 24, 2017
Results First Submitted: October 26, 2018
Results First Posted: March 1, 2019
Last Update Posted: March 1, 2019