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

NCT05298033 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-06-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Stanca Birlea, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2024-04-30
Completion
2024-04-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05298033 on ClinicalTrials.gov