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Phosphodiesterase-4 inhibitor

Crisaborole + PF-07038124 + NBUVB for Vitiligo

Phase 2
Waitlist Available
Led By Stanca Birlea, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active or stable non-segmental vitiligo at Screening and Baseline visits
Agreement to stop all other treatments for vitiligo from screening through 1 week after discontinuation of study drug treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-treatment) and at 3 months (12 weeks) and 6 months (24 weeks)
Awards & highlights

Study Summary

This trial is testing whether a certain type of drug can help improve vitiligo, a condition where patches of skin lose their color. The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the experimental treatment until the trial is over.

Who is the study for?
This trial is for people with non-segmental vitiligo, which includes vitiligo vulgaris or acrofacial vitiligo, that's been diagnosed for at least 3 months. Participants should have a certain amount of facial and body skin affected. They must not be on new medications or changing doses recently, agree to stop other vitiligo treatments during the study, avoid sun exposure and tanning devices, and use contraception if applicable.Check my eligibility
What is being tested?
The trial is testing Crisaborole and PF-07038124 ointments' effectiveness in treating vitiligo both alone and combined with narrow band UVB phototherapy (NBUVB). It's a phase 2A double-blind study where participants are randomly assigned to one of six groups to compare these treatments against sham (fake) therapy.See study design
What are the potential side effects?
Possible side effects may include local skin reactions like burning or itching where the ointment is applied. NBUVB treatment might cause redness or increase the risk of sunburn-like symptoms on treated areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have vitiligo that hasn't changed recently.
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I agree to stop all other vitiligo treatments during the study.
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3%-90% of my body, excluding scalp, palms, and soles, is affected.
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More than half a percent of my face is affected.
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More than a quarter of my face is affected.
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I have been diagnosed with a widespread type of vitiligo for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-treatment) and at 3 months (12 weeks) and 6 months (24 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-treatment) and at 3 months (12 weeks) and 6 months (24 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving at 50% or greater improvement from baseline in facial Vitiligo Area Scoring Index (F)-VASI
Secondary outcome measures
Percentage change from baseline in facial segment of Body Surface Area affected (F-BSA)
Proportion of participants achieving 50% or greater improvement from baseline in total (T)-VASI
Proportion of participants achieving 90% or greater improvement from baseline in F-VASI
+1 more
Other outcome measures
Assessment of melanocyte population expansion via immunohistochemistry (IHC) studies
Assessment of percent change from baseline in serum key inflammatory chemokines
Quantification of pigment via Fontana-Masson staining

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Sham phototherapy plus crisaborole 2% topical ointmentExperimental Treatment2 Interventions
12 participants will receive 6 months of treatment with crisaborole 2% topical ointment combined with 6 months of sham phototherapy
Group II: Sham phototherapy plus PF-07038124 0.01% topical ointmentExperimental Treatment3 Interventions
12 participants will receive 3 months of treatment with PF-07038124 0.01% topical ointment, followed by 3 months of vehicle ointment, along with 6 months of sham phototherapy
Group III: Active NBUVB plus PF-07038124 0.01% topical ointmentExperimental Treatment3 Interventions
12 participants will receive 6 months of treatment with active NBUVB, to be combined with 3 months of treatment with PF-07038124 0.01% topical ointment followed by 3 months of vehicle ointment
Group IV: Active NBUVB plus Crisaborole 2% topical ointmentExperimental Treatment2 Interventions
12 participants will receive 6 months of treatment with crisaborole 2% topical along with 6 months of treatment with active NBUVB
Group V: Active NBUVB plus vehicle ointmentActive Control2 Interventions
8 participants will receive 6 months of treatment with active NBUVB combined with 6 months of vehicle ointment application
Group VI: Sham phototherapy plus vehicle ointmentPlacebo Group2 Interventions
8 participants will receive 6 months of sham phototherapy combined with 6 months of vehicle ointment application
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vehicle
2013
Completed Phase 3
~5070

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,748 Previous Clinical Trials
2,163,934 Total Patients Enrolled
1 Trials studying Vitiligo
47 Patients Enrolled for Vitiligo
PfizerIndustry Sponsor
4,579 Previous Clinical Trials
14,635,168 Total Patients Enrolled
8 Trials studying Vitiligo
184,145 Patients Enrolled for Vitiligo
Stanca Birlea, MDPrincipal InvestigatorUniversity of Colorado, Denver

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to those aged 45 and older?

"In order for individuals to be considered for enrollment in this trial, they must lie between the ages of 18 and 75."

Answered by AI

Are there any vacancies available to join this clinical research study?

"Indeed. The clinical trial is actively seeking participants and the information on clinicaltrials.gov corroborates this fact. It was first published on September 7th 2022 and was last updated on September 12th 2022, with a goal of recruiting 64 patients to one medical centre."

Answered by AI

Has NBUVB phototherapy received authorization from the FDA?

"The safety of NBUVB phototherapy was estimated to be a 2 due its second phase status, indicating the presence of some data explicitly supporting its security but none concerning efficacy."

Answered by AI

How many individuals are enrolled in the experimental research?

"Affirmative, the clinicaltrials.gov website states that this investigation is actively seeking participants. It was first posted on September 7th 2022 with a recent update on September 12th and requires 64 volunteers from a single site to complete the study."

Answered by AI

Is my participation eligible for this experiment?

"This clinical trial is seeking 64 applicants who have been clinically diagnosed with vitiligo for a minimum of 3 months and must fall between the ages 18 to 75. Necessary criteria include: exhibiting BSA >= 0.5% on facial area, having F-VASI & Total VASI scores that are both =>0.5%, agreeing to treatment involving an affected BSA range of 3%-25%, remaining on any concurrent medication regimen without change for duration of study, avoiding exposure to ultraviolet light sources other than those requested by the research team during the study period, and providing signed informed consent in accordance with protocol stipulations."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Colorado
How old are they?
18 - 65
What site did they apply to?
University of Colorado Anschutz - Clinical and Translational Research Centers
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

what is compensation ?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

~0 spots leftby Jun 2024