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

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This is a randomized, double blind, vehicle-controlled clinical trial that includes 64 vitiligo patients. Study patients will be randomly assigned to receive active drugs (crisaborole or PF-07038124 ointment) or vehicle ointment, in combination with active NBUVB or sham-NBUVB.




Participants between 18-75 years of age, inclusive, at the time of informed consent, regardless of sex or ethnicity, are eligible for inclusion. Type of Participant and Disease Characteristics: Active or stable non-segmental vitiligo at Screening and Baseline visits. Eligible participants must meet the following criteria for either active or stable vitiligo: A clinical diagnosis of non-segmental vitiligo (vitiligo vulgaris or acrofacial vitiligo) for at least 3 months; and BSA involvement 3% - 90%, excluding involvement of scalp, palms of the hands, soles of the feet; and BSA >=0.5% involvement of the facial area Participants must agree that the treatment area will involve 3% to 25% BSA.

Active disease state, defined as: non-segmental vitiligo with at least one active lesion, as follows: a. New/extending lesions(s) in the 3 months prior to screening visit (confirmed by photographs or medical record); b. Confetti-like lesion(s); c. Trichrome lesion(s); d. Koebner phenomenon; e. Coexistence of halo (Sutton) nevus/nevi. Stable disease state, defined as: absence of signs of active disease in the last three months. All participants who do not have the features of active vitiligo are required to have stable disease. Participants must agree that the treatment area will involve 3% to 25% BSA. Independent rater confirmation of eligibility is required prior to randomization. Eligibility is based on comparison at the screening visit and Visit 1 and consists of the PI's and independent rater's read scoring of F-VASI, T-VASI, and BSA, using an algorithm to determine whether pre-specified thresholds have been met. Participants for whom one or more PI-read assessments (BSA, F-VASI, or T-VASI) exceed the threshold difference from the read of the independent rater will be screen failed. Informed Consent: All participants must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol. Other Inclusion Criteria: If receiving concomitant medications for any reason other than vitiligo, the participant must be on a stable regimen -- defined as not starting a new drug or changing the drug dosage within 7 days prior to Visit 1 (baseline). Participant must be willing to stay on a stable regimen for the duration of the study. Participants must agree to stop all other treatments for vitiligo from the time of screening through one week subsequent to the discontinuation of topical drug treatment.

Type of Study



CTRC Inpatient
University of Colorado Hospital

Principal Investigator
Photograph of Stanca Birlea,  MD, PhD

Stanca Birlea, MD, PhD

Study ID

Protocol Number: 21-4837

More information available at NCT05298033


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