NCT04091087

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

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Local Tolerability of Crisaborole Ointment, 2%, in Adult Participants With Stasis Dermatitis Without Active Skin Ulceration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study C3291038 is a Phase 2a, randomized, double-blind, vehicle-controlled, parallel-group, proof of concept study to evaluate the efficacy, safety, and local tolerability of 6 weeks of treatment with crisaborole in adult participants with SD without active skin ulceration. Approximately 70 eligible participants will be randomized into the double blind treatment period in a 1:1 ratio to receive crisaborole ointment, 2% or vehicle twice daily for 6 weeks. The study will recruit male and female participants aged ≥ 45 years with a clinical diagnosis of SD. The total duration of participation in the study will be up to 14 weeks, including up to 4 weeks for screening, a 6 week double blind treatment period, and a follow-up period of 4 weeks after treatment completion. Study enrollment and management will be de centralized, where participants do not visit an investigator or a clinic for clinical assessment. The participants will participate in the study at home. The sponsor (or designee) will provide home visits by qualified home visit practitioners (HVP), remote contact by telemedicine (or telephone), and clinical database electronic case report forms (eCRFs), eDiary, and other electronic data entries from 3rd party vendors for study data collection.

Conditions

• Stasis Dermatitis

Interventions

Type	Name	Description
DRUG	crisaborole ointment	crisaborole ointment
OTHER	vehicle ointment	vehicle ointment

Timeline

• Start date: 2020-06-26
• Primary completion: 2021-10-19
• Completion: 2021-10-19
• First posted: 2019-09-16
• Last updated: 2022-05-02
• Results posted: 2022-05-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study