NCT04299503

Topical Crisaborole in Patients with Alopecia Areata

Phase 2 Double Blind Randomized Placebo Controlled Trial of Topical Crisaborole in Patients with Mild-to-Moderate Alopecia Areata

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine whether topical crisaborole improves hair growth in alopecia areata.

Detailed description

Each individual will be enrolled in the study for 24 weeks. Following a 28 days screening period, eligible subjects will be randomized in a 1:1 ratio to receive either crisaborole 2% ointment or matching placebo for 12 weeks. The primary endpoint is assessed at week 12. At the week 12 visit, all subjects will enter the open label treatment period where they will all receive crisaborole 2% ointment for an additional 12 weeks, with the last study visit taking place on week 24.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	Crisaborole Topical Ointment	For every 10% of scalp affected, approximately ½ finger tip of study drug will be needed to cover the area with a thin layer. After the first application at baseline, the tubes will be weighed to determine the dose needed to cover the affected area. This will be the subject's target dose throughout the study
DRUG	Placebo Topical Ointment	For every 10% of scalp affected, approximately ½ finger tip of study drug will be needed to cover the area with a thin layer. After the first application at baseline, the tubes will be weighed to determine the dose needed to cover the affected area. This will be the subject's target dose throughout the study

Timeline

• Start date: 2020-03-06
• Primary completion: 2022-03-01
• Completion: 2022-12-01
• First posted: 2020-03-06
• Last updated: 2024-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study