Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Conditions

• Hand Eczema

Eligibility Criteria

Sex

ALL

Age

18 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 adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).

Key Dates

Start date

Jul 31, 2023

Status verified

Jul 2025

Primary completion

Jul 15, 2024

Completion

Dec 13, 2024

Study Design

Enrollment

186 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib
  Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.
• Placebo Comparator: Vehicle
  Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.

Primary Outcome Measure

Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Week 16 [ Time Frame: Baseline; Week 16 ]

Locations (23)

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