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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
Must not have
Documented lack of response to prior PDE4 inhibitor therapy
Ultraviolet light exposure, including UVB/UVA/PUVA delivered by booth/excimer laser, or tanning bed exposure, requires a washout period of 8 weeks before screening and through the final safety follow-up visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-treatment) and at 3 months (12 weeks) and 6 months (24 weeks)
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I did not improve after taking PDE4 inhibitor medication.
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I haven't been exposed to UV light treatments or tanning beds for 8 weeks.
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Over a third of my vitiligo-affected skin or facial hair is white.
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I do not have any severe illnesses that could worsen by joining this study.
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I have stopped any skin creams or ointments for 2 weeks before my screening.
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I have used skin bleaching treatments for vitiligo or other skin conditions.
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My vitiligo does not fit the common types and may include areas like mucosa or is widespread.
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I am able to use birth control during and for 28 days after the study.
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I haven't taken any immune-modifying drugs in the last 8 weeks.
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I haven't had major surgery or significant trauma in the last month and don't need imminent surgery.

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
Crisaborole
FDA approved
PF-07038124 0.01% topical ointment
2022
Completed Phase 2
~40
NBUVB phototherapy
2022
Completed Phase 2
~40
Sham phototherapy
2022
Completed Phase 2
~40
Vehicle
2013
Completed Phase 3
~5070

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,758 Previous Clinical Trials
2,166,228 Total Patients Enrolled
1 Trials studying Vitiligo
47 Patients Enrolled for Vitiligo
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,868,738 Total Patients Enrolled
8 Trials studying Vitiligo
184,145 Patients Enrolled for Vitiligo
Stanca Birlea, MDPrincipal InvestigatorUniversity of Colorado, Denver
~11 spots leftby Jul 2025
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