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Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360187
Recruitment Status : Completed
First Posted : April 24, 2020
Results First Posted : May 2, 2022
Last Update Posted : June 7, 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
Drug: Crisaborole Placebo Vehicle
Enrollment 391
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description Vehicle was applied BID for 28 days to the Treatable body surface area (BSA) identified at Baseline/Day 1 and new atopic dermatitis (AD) lesions that appear after the Baseline/Day 1. Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Period Title: Double-Blind Treatment
Started 131 260
Completed 108 245
Not Completed 23 15
Reason Not Completed
Adverse Event             9             11
Lack of Efficacy             7             2
Physician Decision             1             0
Withdrawal by Subject             4             2
Withdrawal By Parent/Guardian             2             0
Period Title: Follow-Up
Started 114 232
Completed 113 232
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID) Total
Hide Arm/Group Description Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1. Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1. Total of all reporting groups
Overall Number of Baseline Participants 131 260 391
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 260 participants 391 participants
2-11 Years
69
  52.7%
123
  47.3%
192
  49.1%
12-17 Years
15
  11.5%
25
   9.6%
40
  10.2%
>=18 Years
47
  35.9%
112
  43.1%
159
  40.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 260 participants 391 participants
Female
64
  48.9%
122
  46.9%
186
  47.6%
Male
67
  51.1%
138
  53.1%
205
  52.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 260 participants 391 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
131
 100.0%
260
 100.0%
391
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 260 participants 391 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
131
 100.0%
260
 100.0%
391
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29
Hide Description The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-42.79
(-50.14 to -35.44)
-59.92
(-64.86 to -54.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Twice a Day (BID), Crisaborole 2% Twice a Day (BID)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed effect Model for Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean of difference
Estimated Value -17.13
Confidence Interval (2-Sided) 95%
-25.98 to -8.27
Estimation Comments Crisaborole = Test Vehicle = Reference
2.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description An adverse event was considered as a treatment-emergent adverse event (TEAE) if the event started after the first dose of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. 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. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
Time Frame Baseline up to Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants who were randomized and received at least 1 confirmed dose of investigational product.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Measure Type: Number
Unit of Measure: Percentage of Participants
Participants With Adverse Events 44.3 46.2
Participants With Serious Adverse Events 0.8 0.4
Participants With Severe Adverse Events 1.5 0
Participants Discontinued From Study Due to Adverse Events 0.8 0
3.Primary Outcome
Title Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Hide Description Laboratory parameters included: hematology and chemistry. Clinically significant laboratory abnormalities are defined as abnormal values that have clinical manifestations or require medical intervention. Clinically significant laboratory criteria included Hemoglobin <0.8 x lower limit of normal (LLN), Leukocytes >1.5 x upper limit of normal (ULN), Lymphocytes <0.8 x LLN, Lymphocytes/Leukocytes >1.2 x ULN, Neutrophils <0.8 x LLN, Neutrophils >1.2x ULN, Neutrophils/Leukocytes <0.8 x LLN, Basophils/Leukocytes >1.2 x ULN, Eosinophils >1.2 x ULN, Eosinophils/Leukocytes >1.2 x ULN, Monocytes >1.2 x ULN, Monocytes/Leukocytes (%) >1.2 x ULN, Bicarbonate <0.9 x LLN, and Glucose >1.5x ULN.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who were randomized and received at least 1 confirmed dose of investigational product. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for each row.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 126 258
Measure Type: Number
Unit of Measure: Percentage of Participants
Hemoglobin (g/L) <0.8 x lower limit of normal (LLN) Number Analyzed 124 participants 257 participants
1.6 0
Leukocytes (10^9/L) >1.5 x upper limit of normal (ULN) Number Analyzed 124 participants 257 participants
0 0.4
Lymphocytes (10^9/L) <0.8 x LLN Number Analyzed 124 participants 257 participants
0.8 0
Lymphocytes/Leukocytes (%) >1.2 x ULN Number Analyzed 124 participants 257 participants
3.2 1.9
Neutrophils (10^9/L) <0.8 x LLN Number Analyzed 124 participants 257 participants
0 0.4
Neutrophils (10^9/L) >1.2 x ULN Number Analyzed 124 participants 257 participants
0 0.4
Neutrophils/Leukocytes (%) <0.8 x LLN Number Analyzed 124 participants 257 participants
3.2 2.7
Basophils/Leukocytes (%) >1.2 x ULN Number Analyzed 124 participants 257 participants
4.8 3.1
Eosinophils (10^9/L) >1.2 x ULN Number Analyzed 124 participants 257 participants
33.1 31.1
Eosinophils/Leukocytes (%) >1.2 x ULN Number Analyzed 124 participants 257 participants
29.8 33.1
Monocytes (10^9/L) >1.2 x ULN Number Analyzed 124 participants 257 participants
0 0.4
Monocytes/Leukocytes (%) >1.2 x ULN Number Analyzed 124 participants 257 participants
1.6 1.6
Bicarbonate (mmol/L) <0.9 x LLN Number Analyzed 124 participants 257 participants
0.8 0.8
Glucose (mmol/L) >1.5 x ULN Number Analyzed 126 participants 258 participants
0 0.8
4.Primary Outcome
Title Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Hide Description Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participants in the seated position, after having sat/lied calmly for at least 5 minutes. Clinically significant vital signs criteria included Diastolic Blood Pressure (DBP) Value <50 mmHg, DBP Change ≥20 mmHg increase, DBP Change ≥20 mmHg decrease, Pulse Rate Value >120 beats per minute (bpm), Systolic Blood Pressure (SBP) Value <90 mmHg, SBP Change ≥30 mmHg increase, SBP Change ≥30mmHg decrease
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who were randomized and received at least 1 confirmed dose of investigational product. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure for each row.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 129 259
Measure Type: Number
Unit of Measure: Percentage of Participants
Diastolic Blood Pressure (mmHg) Value <50 mmHg 7.8 7.3
Diastolic Blood Pressure (mmHg) Change ≥20mmHg increase 2.3 3.5
Diastolic Blood Pressure (mmHg) Change ≥20mmHg decrease 3.9 3.1
Pulse Rate (bpm) Value >120 beats per minute (bpm) 2.3 1.9
Systolic Blood Pressure (mmHg) Value <90mmHg 23.3 26.3
Systolic Blood Pressure (mmHg) Change ≥30mmHg increase 0 2.3
Systolic Blood Pressure (mmHg) Change ≥30mmHg decrease 3.1 0.8
5.Secondary Outcome
Title Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29
Hide Description ISGA assessed the severity of atopic dermatitis (AD) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Improvement in ISGA is defined as ISGA score of 0 or 1.
Time Frame Baseline, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
28.5
(20.4 to 36.6)
41.4
(35.4 to 47.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Twice a Day (BID), Crisaborole 2% Twice a Day (BID)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0124
Comments [Not Specified]
Method normal approximation to response rates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.9
Confidence Interval (2-Sided) 95%
2.8 to 23.1
Estimation Comments Crisaborole = Test Vehicle = Reference
6.Secondary Outcome
Title Percentage of Participants Achieving Success in ISGA at Day 29
Hide Description ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
Time Frame Baseline, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
15.9
(9.4 to 22.5)
27.6
(22.1 to 33.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Twice a Day (BID), Crisaborole 2% Twice a Day (BID)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method normal approximation to response rates
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.7
Confidence Interval (2-Sided) 95%
3.1 to 20.3
Estimation Comments Crisaborole = Test Vehicle = Reference
7.Secondary Outcome
Title Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years
Hide Description Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 is no pruritus and 10 is worst itch imaginable. Change: score at Week 4 minus score at baseline.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 62 137
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
-0.79
(-1.18 to -0.40)
-1.58
(-1.84 to -1.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Twice a Day (BID), Crisaborole 2% Twice a Day (BID)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Mixed effect Model for Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.79
Confidence Interval (2-Sided) 95%
-1.26 to -0.33
Estimation Comments Crisaborole = Test Vehicle = Reference
8.Secondary Outcome
Title Percentage of Participants Achieving Success in ISGA Over Time
Hide Description ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
Time Frame Baseline, Day 8, Day 15, Day 22, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Day 8
0.0
(-0.2 to 0.2)
4.8
(2.2 to 7.4)
Day 15
4.9
(1.1 to 8.7)
11.6
(7.6 to 15.6)
Day 22
10.8
(5.2 to 16.3)
18.1
(13.4 to 22.8)
Day 29
15.9
(9.4 to 22.5)
27.6
(22.1 to 33.1)
9.Secondary Outcome
Title Percentage of Participants Achieving Improvement in ISGA Over Time
Hide Description

ISGA (Investigator's Static Global Assessment) assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD.

Improvement in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) .
Time Frame Baseline, Day 8, Day 15, Day 22, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Day 8
7.8
(3.2 to 12.4)
16.8
(12.3 to 21.4)
Day 15
18.3
(11.6 to 25.1)
25.6
(20.2 to 31.0)
Day 22
25.1
(17.4 to 32.7)
32.3
(26.6 to 38.1)
Day 29
28.5
(20.4 to 36.6)
41.4
(35.4 to 47.5)
10.Secondary Outcome
Title Percent Change From Baseline in EASI Total Score Over Time
Hide Description The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Day 8, Day 15, Day 22, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
Day 8
-21.43
(-28.43 to -14.44)
-36.65
(-41.52 to -31.78)
Day 15
-37.15
(-44.24 to -30.05)
-49.65
(-54.53 to -44.76)
Day 22
-42.92
(-50.16 to -35.69)
-55.05
(-59.96 to -50.13)
Day 29
-42.79
(-50.14 to -35.44)
-59.92
(-64.86 to -54.98)
11.Secondary Outcome
Title Change From Baseline in Percent Body Surface Area (%BSA) Over Time
Hide Description 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp was excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated.
Time Frame Baseline, Day 8, Day 15, Day 22, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage BSA
Day 8 Number Analyzed 129 participants 259 participants
-1.75
(-3.37 to -0.13)
-5.12
(-6.26 to -3.98)
Day 15 Number Analyzed 129 participants 259 participants
-3.31
(-4.94 to -1.68)
-7.60
(-8.75 to -6.46)
Day 22 Number Analyzed 129 participants 259 participants
-4.38
(-6.04 to -2.71)
-8.72
(-9.87 to -7.57)
Day 29 Number Analyzed 129 participants 259 participants
-4.81
(-6.50 to -3.11)
-9.89
(-11.05 to -8.73)
12.Secondary Outcome
Title Percentage of Participants Achieving EASI-50 Over Time
Hide Description

The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis.

EASI-50 is defined as EASI score has ≥50% improvement from baseline.
Time Frame Baseline, Day 8, Day 15, Day 22, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Day 8
18.5
(11.8 to 25.1)
37.1
(31.2 to 43.0)
Day 15
32.7
(24.5 to 40.8)
58.9
(52.9 to 65.0)
Day 22
42.2
(33.5 to 50.9)
66.4
(60.7 to 72.2)
Day 29
49.4
(40.5 to 58.2)
72.7
(67.3 to 78.2)
13.Secondary Outcome
Title Percentage of Participants Achieving EASI-75 Over Time
Hide Description

The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis.

EASI-75 is defined as EASI score has ≥75% improvement from baseline.
Time Frame Baseline, Day 8, Day 15, Day 22, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 131 260
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Day 8
6.1
(2.0 to 10.2)
11.2
(7.4 to 15.0)
Day 15
15.4
(9.2 to 21.6)
26.3
(20.9 to 31.7)
Day 22
26.3
(18.6 to 34.0)
38.2
(32.2 to 44.1)
Day 29
27.6
(19.8 to 35.4)
46.4
(40.3 to 52.5)
14.Secondary Outcome
Title Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years
Hide Description

Peak Pruritus NRS is participants-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 is no pruritus and 10 is worst itch imaginable.

Change: score at observation minus score at baseline.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 62 137
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 60 participants 131 participants
-0.38
(-0.75 to -0.01)
-0.94
(-1.19 to -0.69)
Week 2 Number Analyzed 60 participants 131 participants
-0.53
(-0.90 to -0.15)
-1.26
(-1.52 to -1.01)
Week 3 Number Analyzed 60 participants 131 participants
-0.64
(-1.02 to -0.26)
-1.41
(-1.66 to -1.16)
Week 4 Number Analyzed 60 participants 131 participants
-0.79
(-1.18 to -0.40)
-1.58
(-1.84 to -1.33)
15.Secondary Outcome
Title Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years
Hide Description Patient Reported Itch Severity Scale is a 5-point scale indicating no itchy to very itchy (ranged from 0 to 4, where 0=no itch to 4=worst itch imaginable) for participants ≥6 and <12 years of age.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥ 6 and <12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 36 81
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 36 participants 76 participants
-0.26
(-0.47 to -0.05)
-0.51
(-0.66 to -0.36)
Week 2 Number Analyzed 36 participants 76 participants
-0.22
(-0.43 to -0.01)
-0.70
(-0.85 to -0.55)
Week 3 Number Analyzed 36 participants 76 participants
-0.37
(-0.59 to -0.16)
-0.78
(-0.92 to -0.63)
Week 4 Number Analyzed 36 participants 76 participants
-0.52
(-0.74 to -0.30)
-0.86
(-1.00 to -0.71)
16.Secondary Outcome
Title Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years
Hide Description Observer Reported Itch Severity Scale is an 11-point (ranged from 0 to 10, where 0=no itch to 10=worst itch imaginable) scale and must be completed by the observer (caregivers of participants) for participants <6 years of age.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged <6 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 33 42
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 30 participants 41 participants
-0.31
(-0.80 to 0.17)
-1.03
(-1.44 to -0.62)
Week 2 Number Analyzed 30 participants 41 participants
-0.73
(-1.22 to -0.24)
-1.68
(-2.10 to -1.27)
Week 3 Number Analyzed 30 participants 41 participants
-0.96
(-1.46 to -0.47)
-1.79
(-2.21 to -1.38)
Week 4 Number Analyzed 30 participants 41 participants
-1.25
(-1.75 to -0.75)
-1.95
(-2.37 to -1.53)
17.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
Hide Description The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. The questionnaire will be completed by all participants aged 16 years and older, based on the age at Screening Visit/time of informed consent/assent. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥16 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 49 117
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Day 15 Number Analyzed 48 participants 116 participants
-1.1  (4.02) -1.7  (3.57)
Day 29 Number Analyzed 38 participants 110 participants
-1.5  (4.67) -1.8  (4.11)
18.Secondary Outcome
Title Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time
Hide Description The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children's (aged 4-15 years) quality of life. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged 4-15 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 67 127
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Day 15 Number Analyzed 66 participants 125 participants
-1.3  (5.18) -3.6  (4.64)
Day 29 Number Analyzed 59 participants 121 participants
-1.8  (6.00) -3.9  (5.37)
19.Secondary Outcome
Title Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time
Hide Description The IDQOL was completed by observer for participants aged 2-3 years, based on the age at the Screening Visit/time of informed consent/assent. The IDQOL is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score the more quality of life is impaired.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged 2-3 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Day 15 Number Analyzed 14 participants 15 participants
-1.3  (3.34) -3.0  (3.30)
Day 29 Number Analyzed 13 participants 16 participants
-0.7  (3.86) -4.3  (4.44)
20.Secondary Outcome
Title Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time
Hide Description The DFI was completed by all observer for participants aged 2-17 years, based on the age at Screening Visit/time of informed consent/assent. The minimum DFI score is 0; the maximum DFI score is 30. The higher score means worse outcome.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged 2-17 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 84 148
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Day 15 Number Analyzed 82 participants 144 participants
-0.5  (3.87) -2.4  (4.66)
Day 29 Number Analyzed 74 participants 142 participants
-2.1  (4.86) -3.0  (5.22)
21.Secondary Outcome
Title Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years
Hide Description The POEM is a validated 7-item measure used to assess the impact of AD over the past week. The POEM contains 7 symptom based questions with responses rating number of days each symptom is experienced over the past week, from 0 (no days) to 4 (every day), with a maximum score of 28. Higher score means worse outcome.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 62 137
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Day 15 Number Analyzed 61 participants 136 participants
-1.8  (5.25) -5.4  (5.19)
Day 29 Number Analyzed 51 participants 128 participants
-3.3  (5.38) -5.7  (6.32)
22.Secondary Outcome
Title Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years
Hide Description The POEM is a validated 7-item measure used to assess the impact of AD over the past week. The POEM contains 7 symptom based questions with responses rating number of days each symptom is experienced over the past week, from 0 (no days) to 4 (every day), with a maximum score of 28. Higher score means worse outcome.
Time Frame Baseline, Day 15, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥2 and <12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 69 123
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Day 15 Number Analyzed 67 participants 120 participants
-2.5  (5.17) -6.7  (6.09)
Day 29 Number Analyzed 59 participants 119 participants
-3.8  (5.33) -7.7  (5.41)
23.Secondary Outcome
Title Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score
Hide Description

The PGIS (for participants 12 years and older) is a single item patient-rated measure of the participant's AD condition severity at a given point in time.

This single item instrument uses a 7-point rating scale, which range from 1 to 7, where 1=Not present to 7=Extremely severe.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 62 137
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 61 participants 131 participants
-0.24  (0.511) -0.43  (0.649)
Week 2 Number Analyzed 57 participants 128 participants
-0.26  (0.692) -0.60  (0.836)
Week 3 Number Analyzed 52 participants 125 participants
-0.38  (0.871) -0.66  (0.913)
Week 4 Number Analyzed 50 participants 122 participants
-0.44  (0.965) -0.71  (1.028)
24.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Score
Hide Description

The PGIC (for participants 12 years and older) was used to determine global improvement as assessed by the participant or caregiver. It was used as an anchor to define a responder definition for the peak pruritus scales for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' on the peak pruritus scales.

This single item instrument is a 7-point rating scale, anchored by (1) 'very much improved' to (7) 'very much worse'.
Time Frame Day 8, Day 15, Day 22, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 62 137
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Day 8 Number Analyzed 62 participants 137 participants
3.3  (1.05) 2.6  (1.10)
Day 15 Number Analyzed 56 participants 132 participants
3.2  (1.10) 2.6  (1.07)
Day 22 Number Analyzed 51 participants 127 participants
3.0  (1.19) 2.6  (1.04)
Day 29 Number Analyzed 50 participants 126 participants
2.9  (1.21) 2.5  (1.12)
25.Secondary Outcome
Title Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score
Hide Description

The OGIS (for participants ≥2 and <12 years) is a single item observer-rated measure of the participant's AD condition severity at a given point in time.

This single item instrument uses a 7-point rating scale, which ranged from 1 to 7, where 1=Not present to 7=Extremely severe.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥2 and <12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 69 123
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 1 Number Analyzed 66 participants 117 participants
-0.12  (0.593) -0.62  (0.667)
Week 2 Number Analyzed 64 participants 115 participants
-0.27  (0.617) -0.93  (0.794)
Week 3 Number Analyzed 61 participants 116 participants
-0.41  (0.770) -1.03  (0.822)
Week 4 Number Analyzed 59 participants 115 participants
-0.54  (0.854) -1.14  (0.893)
26.Secondary Outcome
Title Observer Reported Global Impression of Change (OGIC) Score
Hide Description

The OGIC (for participants ≥2 and <12 years ) was used to determine global improvement as assessed by the participant or caregiver. It was used as an anchor to define a responder definition for the peak pruritus scales for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' on the peak pruritus scales.

This single item instrument is a 7-point rating scale, anchored by (1) 'very much improved' to (7) 'very much worse'.
Time Frame Day 8, Day 15, Day 22, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥2 and <12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description:
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
Overall Number of Participants Analyzed 69 123
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Day 8 Number Analyzed 67 participants 121 participants
3.0  (1.08) 2.3  (0.81)
Day 15 Number Analyzed 64 participants 118 participants
3.0  (1.10) 2.3  (0.92)
Day 22 Number Analyzed 58 participants 120 participants
2.9  (1.16) 2.4  (0.99)
Day 29 Number Analyzed 57 participants 118 participants
2.8  (1.07) 2.2  (1.05)
Time Frame Baseline up to Day 60
Adverse Event Reporting Description Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
 
Arm/Group Title Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Hide Arm/Group Description Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1. Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
All-Cause Mortality
Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/260 (0.00%) 
Hide Serious Adverse Events
Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/131 (0.76%)   1/260 (0.38%) 
Investigations     
Myocardial necrosis marker increased * 1  1/131 (0.76%)  0/260 (0.00%) 
Nervous system disorders     
Carpal tunnel syndrome * 1  0/131 (0.00%)  1/260 (0.38%) 
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Vehicle Twice a Day (BID) Crisaborole 2% Twice a Day (BID)
Affected / at Risk (%) Affected / at Risk (%)
Total   43/131 (32.82%)   101/260 (38.85%) 
General disorders     
Application site discolouration * 1  1/131 (0.76%)  9/260 (3.46%) 
Application site irritation * 1  1/131 (0.76%)  3/260 (1.15%) 
Application site pain * 1  5/131 (3.82%)  34/260 (13.08%) 
Application site paraesthesia * 1  1/131 (0.76%)  7/260 (2.69%) 
Application site urticaria * 1  0/131 (0.00%)  3/260 (1.15%) 
Pyrexia * 1  1/131 (0.76%)  6/260 (2.31%) 
Infections and infestations     
Conjunctivitis * 1  2/131 (1.53%)  3/260 (1.15%) 
Folliculitis * 1  6/131 (4.58%)  8/260 (3.08%) 
Gastroenteritis * 1  0/131 (0.00%)  3/260 (1.15%) 
Nasopharyngitis * 1  4/131 (3.05%)  9/260 (3.46%) 
Otitis media acute * 1  2/131 (1.53%)  1/260 (0.38%) 
Pharyngitis * 1  2/131 (1.53%)  3/260 (1.15%) 
Tonsillitis * 1  0/131 (0.00%)  3/260 (1.15%) 
Upper respiratory tract infection * 1  4/131 (3.05%)  9/260 (3.46%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  0/131 (0.00%)  3/260 (1.15%) 
Skin and subcutaneous tissue disorders     
Acne * 1  3/131 (2.29%)  4/260 (1.54%) 
Dermatitis atopic * 1  15/131 (11.45%)  20/260 (7.69%) 
Dermatitis contact * 1  1/131 (0.76%)  6/260 (2.31%) 
Miliaria * 1  2/131 (1.53%)  0/260 (0.00%) 
Pruritus * 1  3/131 (2.29%)  0/260 (0.00%) 
Urticaria * 1  1/131 (0.76%)  3/260 (1.15%) 
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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: NCT04360187    
Other Study ID Numbers: C3291032
First Submitted: April 4, 2020
First Posted: April 24, 2020
Results First Submitted: April 3, 2022
Results First Posted: May 2, 2022
Last Update Posted: June 7, 2022