Trial Outcomes & Findings for A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD (NCT NCT03539601)

NCT ID: NCT03539601

Last Updated: 2022-01-10

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 237 participants
• Primary outcome timeframe: Baseline, Day 29
• Results posted on: 2022-01-10

Participant Flow

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.

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%).

Participant milestones

Measure	Vehicle 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% BID 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% BID 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% BID 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 Study STARTED	60	59	71	47
Overall Study Treated	59	58	71	47
Overall Study COMPLETED	54	52	65	46
Overall Study NOT COMPLETED	6	7	6	1

Reasons for withdrawal

Measure	Vehicle 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% BID 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% BID 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% BID 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 Study Withdraw by parent/guardian	1	0	1	0
Overall Study Adverse Event	0	2	0	0
Overall Study Lost to Follow-up	2	4	5	0
Overall Study Withdrawal by Subject	2	0	0	1
Overall Study Randomized but not treated	1	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Vehicle n=59 Participants 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% BID n=58 Participants 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% BID n=71 Participants 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% BID n=47 Participants 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 n=235 Participants Total of all reporting groups
Age, Continuous	19.8 Years STANDARD_DEVIATION 18.22 • n=5 Participants	21.5 Years STANDARD_DEVIATION 19.12 • n=7 Participants	19.6 Years STANDARD_DEVIATION 16.28 • n=5 Participants	21.1 Years STANDARD_DEVIATION 18.20 • n=4 Participants	20.4 Years STANDARD_DEVIATION 17.79 • n=21 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	35 Participants n=7 Participants	43 Participants n=5 Participants	26 Participants n=4 Participants	139 Participants n=21 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	23 Participants n=7 Participants	28 Participants n=5 Participants	21 Participants n=4 Participants	96 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants	4 Participants n=4 Participants	22 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	57 Participants n=7 Participants	60 Participants n=5 Participants	43 Participants n=4 Participants	213 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants	6 Participants n=4 Participants	60 Participants n=21 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	38 Participants n=7 Participants	44 Participants n=5 Participants	37 Participants n=4 Participants	157 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Day 29

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=31 Participants 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% BID: Participants 2-17 Years n=31 Participants 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% BID: Participants 2-17 Years n=36 Participants 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% BID: Participants 2-17 Years n=29 Participants 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: Participants >=18 Years n=17 Participants 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% BID: Participants >=18 Years n=19 Participants 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% BID: Participants >=18 Years n=29 Participants 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% BID: Participants >=18 Years n=14 Participants 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.
Percent Change From Baseline in the Eczema Area and Severity Index (EASI) Total Score at Day 29	-26.62 Percent change Standard Deviation 46.283	-49.47 Percent change Standard Deviation 34.195	-75.50 Percent change Standard Deviation 30.305	-60.08 Percent change Standard Deviation 31.877	-44.67 Percent change Standard Deviation 49.267	-57.14 Percent change Standard Deviation 48.345	-70.29 Percent change Standard Deviation 32.097	-62.59 Percent change Standard Deviation 28.317

PRIMARY outcome

Timeframe: From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days)

Population: Safety analysis set included all participants who received at least 1 dose of the investigational product according to actual treatment received.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=59 Participants 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% BID: Participants 2-17 Years n=58 Participants 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% BID: Participants 2-17 Years n=71 Participants 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% BID: Participants 2-17 Years n=47 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Discontinuations Due to AEs and SAEs Discontinuation due to AEs	0 Participants	3 Participants	0 Participants	0 Participants	—	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Discontinuations Due to AEs and SAEs TEAEs	18 Participants	25 Participants	12 Participants	24 Participants	—	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Discontinuations Due to AEs and SAEs SAEs	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Discontinuations Due to AEs and SAEs Discontinuation due to SAEs	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days)

Population: Safety analysis set included all participants who received at least 1 dose of the investigational product according to actual treatment received.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=59 Participants 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% BID: Participants 2-17 Years n=58 Participants 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% BID: Participants 2-17 Years n=71 Participants 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% BID: Participants 2-17 Years n=47 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
Number of Participants With Local Tolerability Adverse Events (AEs)	12 Participants	13 Participants	2 Participants	8 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Screening up to Day 29

Population: Safety analysis set included all participants who received at least 1 dose of the investigational product according to actual treatment received.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=59 Participants 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% BID: Participants 2-17 Years n=58 Participants 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% BID: Participants 2-17 Years n=71 Participants 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% BID: Participants 2-17 Years n=47 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
Number of Participants With Clinically Significant Changes in Vital Signs	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Screening up to Day 29

Population: Safety analysis set included all participants who received at least 1 dose of the investigational product according to actual treatment received.

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).

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=59 Participants 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% BID: Participants 2-17 Years n=58 Participants 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% BID: Participants 2-17 Years n=71 Participants 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% BID: Participants 2-17 Years n=47 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
Number of Participants With Clinically Significant Abnormal Laboratory Parameters	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 8, 15 and 22

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=38 Participants 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% BID: Participants 2-17 Years n=37 Participants 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% BID: Participants 2-17 Years n=38 Participants 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% BID: Participants 2-17 Years n=30 Participants 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: Participants >=18 Years n=21 Participants 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% BID: Participants >=18 Years n=21 Participants 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% BID: Participants >=18 Years n=32 Participants 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% BID: Participants >=18 Years n=17 Participants 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.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 8, 15 and 22 Percent Change at Day 15	-25.77 Percent change Standard Deviation 35.658	-36.72 Percent change Standard Deviation 36.625	-58.96 Percent change Standard Deviation 32.617	-42.75 Percent change Standard Deviation 31.854	-25.93 Percent change Standard Deviation 31.690	-48.42 Percent change Standard Deviation 33.458	-56.29 Percent change Standard Deviation 32.186	-37.18 Percent change Standard Deviation 50.487
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 8, 15 and 22 Percent Change at Day 8	-17.88 Percent change Standard Deviation 36.705	-26.79 Percent change Standard Deviation 39.280	-45.59 Percent change Standard Deviation 28.103	-34.20 Percent change Standard Deviation 25.972	-14.77 Percent change Standard Deviation 26.308	-29.83 Percent change Standard Deviation 44.599	-42.48 Percent change Standard Deviation 27.843	-18.75 Percent change Standard Deviation 39.016
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 8, 15 and 22 Percent Change at Day 22	-25.07 Percent change Standard Deviation 49.326	-38.87 Percent change Standard Deviation 32.624	-69.09 Percent change Standard Deviation 31.528	-59.86 Percent change Standard Deviation 24.835	-34.43 Percent change Standard Deviation 30.587	-56.05 Percent change Standard Deviation 38.934	-61.82 Percent change Standard Deviation 27.894	-42.25 Percent change Standard Deviation 40.192

SECONDARY outcome

Timeframe: Day 8, 15, 22 and 29

Population: FAS included all randomized participants who received at least 1 dose of investigational product.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=38 Participants 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% BID: Participants 2-17 Years n=37 Participants 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% BID: Participants 2-17 Years n=39 Participants 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% BID: Participants 2-17 Years n=30 Participants 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: Participants >=18 Years n=21 Participants 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% BID: Participants >=18 Years n=21 Participants 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% BID: Participants >=18 Years n=32 Participants 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% BID: Participants >=18 Years n=17 Participants 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.
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 Day 8	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
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 Day 15	1 Participants	3 Participants	8 Participants	2 Participants	0 Participants	0 Participants	6 Participants	1 Participants
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 Day 22	2 Participants	2 Participants	11 Participants	5 Participants	1 Participants	3 Participants	9 Participants	1 Participants
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 Day 29	2 Participants	5 Participants	20 Participants	7 Participants	3 Participants	6 Participants	13 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 8, 15, 22 and 29

Population: FAS included all randomized participants who received at least 1 dose of investigational product.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=38 Participants 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% BID: Participants 2-17 Years n=37 Participants 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% BID: Participants 2-17 Years n=39 Participants 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% BID: Participants 2-17 Years n=30 Participants 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: Participants >=18 Years n=21 Participants 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% BID: Participants >=18 Years n=21 Participants 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% BID: Participants >=18 Years n=32 Participants 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% BID: Participants >=18 Years n=17 Participants 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.
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 Day 22	6 Participants	8 Participants	19 Participants	9 Participants	1 Participants	8 Participants	13 Participants	5 Participants
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 Day 29	6 Participants	10 Participants	27 Participants	13 Participants	4 Participants	9 Participants	20 Participants	7 Participants
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 Day 8	6 Participants	3 Participants	12 Participants	5 Participants	0 Participants	4 Participants	4 Participants	2 Participants
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 Day 15	6 Participants	7 Participants	19 Participants	9 Participants	1 Participants	3 Participants	11 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=59 Participants 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% BID: Participants 2-17 Years n=58 Participants 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% BID: Participants 2-17 Years n=70 Participants 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% BID: Participants 2-17 Years n=47 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
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 Day 8	2 Participants	7 Participants	9 Participants	2 Participants	—	—	—	—
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 Day 15	4 Participants	10 Participants	25 Participants	8 Participants	—	—	—	—
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 Day 22	8 Participants	13 Participants	29 Participants	11 Participants	—	—	—	—
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 Day 29	9 Participants	17 Participants	40 Participants	17 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 43

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=59 Participants 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% BID: Participants 2-17 Years n=58 Participants 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% BID: Participants 2-17 Years n=70 Participants 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% BID: Participants 2-17 Years n=47 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
Time to First Improvement From Baseline in Eczema Area and Severity Index (EASI) Total Score of Greater Than or Equal to (>=) 75%	NA Days Median and 95% CI could not be estimated because there were insufficient number of participants with event.	43.0 Days Interval 28.0 to Upper limit for 95% CI could not be estimated because there were insufficient number of participants with events to calculate the full 95% CI.	23.0 Days Interval 16.0 to 34.0	32.0 Days Interval 27.0 to Upper limit for 95% CI could not be estimated because there were insufficient number of participants with events to calculate the full 95% CI.	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=38 Participants 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% BID: Participants 2-17 Years n=37 Participants 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% BID: Participants 2-17 Years n=39 Participants 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% BID: Participants 2-17 Years n=30 Participants 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: Participants >=18 Years n=21 Participants 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% BID: Participants >=18 Years n=21 Participants 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% BID: Participants >=18 Years n=32 Participants 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% BID: Participants >=18 Years n=17 Participants 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.
Change From Baseline in Percent Body Surface Area (%BSA) at Day 8, 15, 22 and 29 Change at Day 8	-2.04 Percent BSA Standard Deviation 7.533	-2.63 Percent BSA Standard Deviation 11.920	-5.25 Percent BSA Standard Deviation 8.346	-2.84 Percent BSA Standard Deviation 5.296	-1.39 Percent BSA Standard Deviation 4.417	-4.09 Percent BSA Standard Deviation 6.397	-2.74 Percent BSA Standard Deviation 2.718	-1.44 Percent BSA Standard Deviation 5.600
Change From Baseline in Percent Body Surface Area (%BSA) at Day 8, 15, 22 and 29 Change at Day 22	-2.23 Percent BSA Standard Deviation 12.321	-7.14 Percent BSA Standard Deviation 10.123	-8.54 Percent BSA Standard Deviation 11.226	-6.52 Percent BSA Standard Deviation 9.883	-4.19 Percent BSA Standard Deviation 5.464	-5.98 Percent BSA Standard Deviation 7.852	-4.91 Percent BSA Standard Deviation 5.190	-4.17 Percent BSA Standard Deviation 5.588
Change From Baseline in Percent Body Surface Area (%BSA) at Day 8, 15, 22 and 29 Change at Day 29	-3.38 Percent BSA Standard Deviation 9.974	-9.95 Percent BSA Standard Deviation 11.324	-9.63 Percent BSA Standard Deviation 12.309	-7.30 Percent BSA Standard Deviation 10.774	-6.76 Percent BSA Standard Deviation 8.089	-7.18 Percent BSA Standard Deviation 8.183	-7.18 Percent BSA Standard Deviation 5.971	-6.86 Percent BSA Standard Deviation 8.172
Change From Baseline in Percent Body Surface Area (%BSA) at Day 8, 15, 22 and 29 Change at Day 15	-2.38 Percent BSA Standard Deviation 8.566	-4.32 Percent BSA Standard Deviation 12.620	-7.40 Percent BSA Standard Deviation 9.515	-3.72 Percent BSA Standard Deviation 4.401	-3.73 Percent BSA Standard Deviation 5.895	-4.63 Percent BSA Standard Deviation 7.211	-5.00 Percent BSA Standard Deviation 5.189	-3.56 Percent BSA Standard Deviation 5.750

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=33 Participants 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% BID: Participants 2-17 Years n=33 Participants 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% BID: Participants 2-17 Years n=45 Participants 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% BID: Participants 2-17 Years n=28 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
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 Change at Day 8	-0.67 Units on a scale Standard Deviation 1.254	-1.01 Units on a scale Standard Deviation 1.145	-2.24 Units on a scale Standard Deviation 2.065	-0.29 Units on a scale Standard Deviation 1.225	—	—	—	—
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 Change at Day 15	-0.97 Units on a scale Standard Deviation 1.778	-1.08 Units on a scale Standard Deviation 1.419	-3.21 Units on a scale Standard Deviation 2.598	-1.35 Units on a scale Standard Deviation 1.707	—	—	—	—
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 Change at Day 22	-0.98 Units on a scale Standard Deviation 1.887	-1.28 Units on a scale Standard Deviation 1.642	-3.83 Units on a scale Standard Deviation 2.554	-1.66 Units on a scale Standard Deviation 1.759	—	—	—	—
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 Change at Day 29	-1.30 Units on a scale Standard Deviation 2.157	-1.65 Units on a scale Standard Deviation 1.996	-4.02 Units on a scale Standard Deviation 2.734	-1.67 Units on a scale Standard Deviation 1.952	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Day 29

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Day 29

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Day 29

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Day 29

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=31 Participants 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% BID: Participants 2-17 Years n=32 Participants 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% BID: Participants 2-17 Years n=42 Participants 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% BID: Participants 2-17 Years n=26 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
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 Day 8	3 Participants	7 Participants	21 Participants	1 Participants	—	—	—	—
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 Day 15	9 Participants	8 Participants	31 Participants	7 Participants	—	—	—	—
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 Day 29	10 Participants	9 Participants	32 Participants	9 Participants	—	—	—	—
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 Day 22	9 Participants	7 Participants	32 Participants	9 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=29 Participants 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% BID: Participants 2-17 Years n=29 Participants 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% BID: Participants 2-17 Years n=40 Participants 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% BID: Participants 2-17 Years n=26 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
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 Day 8	2 Participants	1 Participants	11 Participants	0 Participants	—	—	—	—
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 Day 15	5 Participants	5 Participants	21 Participants	3 Participants	—	—	—	—
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 Day 29	6 Participants	6 Participants	24 Participants	6 Participants	—	—	—	—
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 Day 22	4 Participants	4 Participants	25 Participants	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=23 Participants 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% BID: Participants 2-17 Years n=26 Participants 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% BID: Participants 2-17 Years n=32 Participants 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% BID: Participants 2-17 Years n=23 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
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 Change at Day 22	-2.8 Units on a scale Standard Deviation 4.12	-3.4 Units on a scale Standard Deviation 4.73	-6.9 Units on a scale Standard Deviation 6.37	-3.4 Units on a scale Standard Deviation 3.88	—	—	—	—
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 Change at Day 29	-4.9 Units on a scale Standard Deviation 5.60	-3.9 Units on a scale Standard Deviation 4.76	-7.0 Units on a scale Standard Deviation 6.69	-4.1 Units on a scale Standard Deviation 3.76	—	—	—	—
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 Change at Day 8	-1.9 Units on a scale Standard Deviation 5.53	-3.8 Units on a scale Standard Deviation 3.45	-5.1 Units on a scale Standard Deviation 4.98	-1.4 Units on a scale Standard Deviation 2.99	—	—	—	—
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 Change at Day 15	-3.4 Units on a scale Standard Deviation 3.72	-3.5 Units on a scale Standard Deviation 2.92	-6.8 Units on a scale Standard Deviation 5.94	-2.9 Units on a scale Standard Deviation 2.63	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=27 Participants 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% BID: Participants 2-17 Years n=26 Participants 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% BID: Participants 2-17 Years n=30 Participants 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% BID: Participants 2-17 Years n=18 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants Aged 4-15 Years at Day 8, 15, 22 and 29 Change at Day 8	-0.2 Units on a scale Standard Deviation 3.42	-2.1 Units on a scale Standard Deviation 4.49	-5.4 Units on a scale Standard Deviation 6.14	-1.7 Units on a scale Standard Deviation 4.03	—	—	—	—
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants Aged 4-15 Years at Day 8, 15, 22 and 29 Change at Day 15	-2.0 Units on a scale Standard Deviation 4.49	-3.1 Units on a scale Standard Deviation 5.13	-5.5 Units on a scale Standard Deviation 6.32	-1.6 Units on a scale Standard Deviation 4.66	—	—	—	—
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants Aged 4-15 Years at Day 8, 15, 22 and 29 Change at Day 29	-3.1 Units on a scale Standard Deviation 2.73	-3.4 Units on a scale Standard Deviation 4.85	-6.4 Units on a scale Standard Deviation 5.49	-3.4 Units on a scale Standard Deviation 3.52	—	—	—	—
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants Aged 4-15 Years at Day 8, 15, 22 and 29 Change at Day 22	-2.7 Units on a scale Standard Deviation 3.04	-2.6 Units on a scale Standard Deviation 5.81	-4.9 Units on a scale Standard Deviation 7.89	-2.5 Units on a scale Standard Deviation 3.15	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22 and 29

Population: 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.

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.

Outcome measures

Measure	Vehicle: Participants 2-17 Years n=38 Participants 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% BID: Participants 2-17 Years n=37 Participants 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% BID: Participants 2-17 Years n=39 Participants 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% BID: Participants 2-17 Years n=30 Participants 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: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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% BID: Participants >=18 Years 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.
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) in Participants Aged 2-17 Years at Day 8, 15, 22 and 29 Change at Day 8	-1.2 Units on a scale Standard Deviation 6.43	-2.3 Units on a scale Standard Deviation 5.16	-5.6 Units on a scale Standard Deviation 5.61	-2.8 Units on a scale Standard Deviation 6.79	—	—	—	—
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) in Participants Aged 2-17 Years at Day 8, 15, 22 and 29 Change at Day 15	-1.1 Units on a scale Standard Deviation 6.77	-2.3 Units on a scale Standard Deviation 4.71	-5.5 Units on a scale Standard Deviation 6.82	-3.2 Units on a scale Standard Deviation 5.94	—	—	—	—
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) in Participants Aged 2-17 Years at Day 8, 15, 22 and 29 Change at Day 22	-2.5 Units on a scale Standard Deviation 4.84	-3.1 Units on a scale Standard Deviation 5.24	-5.3 Units on a scale Standard Deviation 6.92	-4.5 Units on a scale Standard Deviation 5.93	—	—	—	—
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) in Participants Aged 2-17 Years at Day 8, 15, 22 and 29 Change at Day 29	-1.8 Units on a scale Standard Deviation 5.26	-3.6 Units on a scale Standard Deviation 4.40	-6.4 Units on a scale Standard Deviation 5.61	-4.8 Units on a scale Standard Deviation 5.61	—	—	—	—

Adverse Events

Vehicle

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Crisaborole Ointment 2% BID

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Hydrocortisone Butyrate Cream 0.1% BID

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Pimecrolimus Cream 1% BID

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vehicle n=59 participants at risk 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% BID n=58 participants at risk 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% BID n=71 participants at risk 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% BID n=47 participants at risk 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.
Nervous system disorders Headache	1.7% 1/59 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	5.2% 3/58 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	2.8% 2/71 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	4.3% 2/47 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.
Skin and subcutaneous tissue disorders Dermatitis atopic	11.9% 7/59 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	6.9% 4/58 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	2.8% 2/71 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	14.9% 7/47 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/59 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	5.2% 3/58 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	0.00% 0/71 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	2.1% 1/47 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.
Infections and infestations Nasopharyngitis	3.4% 2/59 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	5.2% 3/58 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	0.00% 0/71 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	6.4% 3/47 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.
Infections and infestations Rhinitis	0.00% 0/59 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	3.4% 2/58 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	1.4% 1/71 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	6.4% 3/47 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.
General disorders Application site pain	1.7% 1/59 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	13.8% 8/58 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	0.00% 0/71 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.	4.3% 2/47 • Day 1 up to 28 days after last dose of study treatment (maximum up to 60 days) 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.

Additional Information

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Results disclosure agreements

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