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

Approximately 600 subjects will be enrolled in the study, of which at least 150 subjects aged
2-6; at least 140 subjects aged 7-11; at least 120 subjects aged 12-17 and up to 90 subjects
will be adults. Subjects must have mild-moderate AD involving at least 5% treatable %BSA
assessed on baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's
total body surface area that is AD involved, excluding the scalp.

Eligible subjects will be randomized at the Baseline/Day 1 visit. Randomization will be
stratified by eligibility for TCS or TCI treatment as per national approved labels. Cohort 1
will be for subjects who are eligible for TCS therapy, and Cohort 2 will be for subjects who
are not eligible for TCS therapy but eligible for TCI therapy. The investigational products
will be applied BID for 28 days to the Treatable body surface area (BSA) identified at
Baseline/Day 1.

The primary efficacy endpoint is the percent change from baseline in the Eczema Area and
Severity Index (EASI) total score at Day 29.

For the efficacy comparison of crisaborole versus vehicle, subjects from both Cohort 1 and
Cohort 2 are included in the analysis, adjusted for cohort effect. For the efficacy
comparison of crisaborole versus TCS, only subjects from Cohort 1 are included in the
analysis. For the comparison of crisaborole versus TCI, only subjects from Cohort 2 are
included in the analysis.

Safety and efficacy assessments will be conducted at the investigator site by a clinical
assessor blinded to treatment assignment.

Scheduled study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8, Day
15, Day 22, Day 29 (End of treatment/Early termination). A follow up telephone call will be
made by site staff to the subjects/subject's legally acceptable guardian(s) on Day 36 and Day
60.

Inclusion Criteria:

Is male or female 2 years and older at the Screening visit/time of informed consent/assent
diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at
least 5% BSA.

Exclusion Criteria:

Has any clinically significant medical disorder, condition, or disease (including active or
potentially recurrent non AD dermatological conditions and known genetic dermatological
conditions that overlap with AD, such as Netherton syndrome.

Subjects in Cohort 1 are excluded if they have a contraindication for treatment with
hydrocortisone butyrate cream 0.1%

Subjects in Cohort 2 are excluded if they have a contraindication for treatment with
pimecrolimus cream, 1%