Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis
Summary
This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).
Timeline
- Start
- 2019-06-15
- Primary completion
- 2019-12-16
- Completion
- 2019-12-16
Outcome
Met primary endpoint
registry analysis (superiority test); Crisaborole 2% QD: Age Group >=12 Years vs Vehicle QD: Age Group >=12 Years; p = 0.0071; Least squares mean of difference -1.6 (95% CI -2.7 to -0.5); Mixed Models Analysis NCT03954158 ↗
registry analysis (superiority test); Crisaborole 2% BID: Age Group >=12 Years vs Vehicle BID: Age Group >=12 Years; p = 0.0029; Least squares mean of difference -2.0 (95% CI -3.3 to -0.8); Mixed Models Analysis NCT03954158 ↗
registry analysis (superiority test); Crisaborole 2% QD: Age Group 2 to 11 Years vs Vehicle QD: Age Group 2 to 11 Years; p = 0.0250; Least squares mean of difference -1.5 (95% CI -2.7 to -0.2); Mixed Models Analysis NCT03954158 ↗
registry analysis (superiority test); Crisaborole 2% BID: Age Group 2 to 11 Years vs Vehicle BID: Age Group 2 to 11 Years; p = 0.0014; Least squares mean of difference -2.1 (95% CI -3.3 to -0.9); Mixed Models Analysis NCT03954158 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crisaborole | Small molecule | 2 % | — |