NCT05298033

Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo

Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo: A Phase 2A Randomized, Double-Blind, Vehicle-Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2A clinical trial designed to test the pro-melanogenic and anti-inflammatory role of phosphodiesterase-4 inhibitors (PDE4i), alone and in combination with active narrow band UVB (NBUVB), in vitiligo lesions. This is a double-blind, randomized controlled trial (RCT) with six study arms. The goal is for 64 participants to be recruited and complete the study.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Crisaborole 2 % Topical Ointment	Twice daily crisaborole 2% topical ointment
DRUG	PF-07038124 0.01% topical ointment	Twice daily PF-07038124 0.01% topical ointment
DEVICE	NBUVB phototherapy	Home narrow band UVB phototherapy exposure sessions 3 times per week
DEVICE	Sham phototherapy	Non-NBUVB visible light radiation exposure sessions 3 times per week
DRUG	Vehicle	Twice daily vehicle ointment

Timeline

• Start date: 2022-09-07
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2022-03-28
• Last updated: 2024-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study