Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

Conditions

• Non-segmental Vitiligo

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib cream — DRUG
  Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
• Vehicle — DRUG
  Vehicle cream is a topical formulation applied as a thin film to affected areas.

Study Details

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Key Dates

Start date

Sep 20, 2019

Status verified

Aug 2025

Primary completion

Mar 18, 2021

Completion

Oct 21, 2021

Study Design

Enrollment

330 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Double-Blind Period: Ruxolitinib cream 1.5% BID
  Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
• Placebo Comparator: Double-Blind Period: Vehicle cream BID
  Participants applied matching vehicle cream BID for 24 weeks.
• Experimental: Treatment-Extension Period: Ruxolitinib cream 1.5% BID
  Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
• Experimental: Treatment-Extension Period: Vehicle cream to Ruxolitinib cream 1.5% BID
  Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period.

Primary Outcome Measure

Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 [ Time Frame: Baseline; Week 24 ]

Locations (29)

Find similar trials in Hoover, AL

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