Stopped: This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.
This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to \<18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites.
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Percent Change From Baseline in the Eczema Area and Severity Index (EASI) Total Score at Day 29
Timeframe: Baseline, Day 29
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Discontinuations Due to AEs and SAEs
Timeframe: From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days)
Number of Participants With Local Tolerability Adverse Events (AEs)
Timeframe: From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days)
Number of Participants With Clinically Significant Changes in Vital Signs
Timeframe: Screening up to Day 29
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Timeframe: Screening up to Day 29