- Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history
prior to Screening and that has been clinically stable for 1 month.
- Investigator's Static Global Assessment (ISGA) of 2 (mild) or 3 (moderate) at
- Body surface area (BSA) covered with AD of at least 0.5% and no more than 10% at
Baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back
of the hands, and soles.
- Two lesions of AD at least 3 cm x 3 cm in size and at least 5 cm apart, with identical
Lesion ISGA score of greater than/equal to 3.
- Clinically infected AD or requires high potency topical corticosteroids or systemic
(oral/injectable) corticosteroids to manage AD.
- History of angioedema or anaphylaxis to topical products or known sensitivity to
components of crisaborole ointment 2%.
- History of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the
- Previous treatment with any topical or systemic PDE4 inhibitor unless stopped for the
reason of lack of efficacy.