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

• Status: Completed
• Trial end date: 2021-10-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Participants who are ≥45 years of age and in generally stable health

• Participants who are in generally stable health and have a known diagnosis of Stasis Dermatitis or newly diagnosed Stasis Dermatitis

• Participants whose mental and physical status allows them to be able to mostly perform their activities of daily living with minimal assistance

Exclusion Criteria:

• Participants with clinically significant active or potentially recurrent dermatitis conditions and known genetic dermatological conditions that are not Stasis Dermatitis or overlap with Stasis Dermatitis

• Participants with active venous stasis ulceration on either lower extremity.

• Participants with current infection or suspected infection of any Stasis Dermatitis lesions

• Women of child bearing potential (WOCBP) are not eligible for this study