Back to Results

TRuE-V MOA

Title A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action Ruxolitinib Cream for Vitiligo (TRuE-V MOA)
Therapeutic Area Vitiligo
Principal Investigator David Rosmarin, MD
Min Age 18 Years
Gender Any
Contact Nicole Dumont
617-636-7462
ndonovan1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04896385

Overview

To evaluate the change in immune biomarkers in participants with vitiligo

Study Details

Inclusion Criteria

  • A clinical diagnosis of non-segmental vitiligo with depigmented areas including  ≥ 0.5% BSA on the face,  ≥ 0.5 F-VASI,  ≥ 3% BSA on non-facial areas, and  ≥ 3 T-VASI
  • Total body vitiligo area (facial and non-facial) should not exceed 50% BSA
  • At least 1 active vitiligo lesion (e.g. such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy

Exclusion Criteria

  • No pigmented hair within any of the vitiligo areas on the face
  • Used depigmentation treatments (e.g. monobenzone) for past treatment with vitiligo or other pigmented areas

Study Requirements

Screening is up to 42 days (~6 weeks); the double-blind, vehicle-controlled treatment period is 24 weeks; the open-label treatment extension period is 28 weeks; and safety follow-up is 30 days. Total duration is up to approximately 63 weeks