Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis

Summary

This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will receive crisaborole ointment 2% or vehicle twice daily for 6 weeks.

Timeline

Start

2020-06-26

Primary completion

2021-10-19

Completion

2021-10-19

Outcome

Met primary endpoint

registry analysis (superiority test); Vehicle Ointment vs Crisaborole 2% Ointment; p = 0.0299; Least square (LS) mean difference -14.36 (90% CI -26.87 to -1.86); ANOVA; note: 1-sided NCT04091087 ↗

Drugs

Indications