Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

Conditions

• Hand Eczema

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

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

Jan 31, 2023

Status verified

Nov 2022

Primary completion

Apr 25, 2024

Completion

Sep 22, 2024

Study Design

Enrollment

0 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

Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) [ Time Frame: Week 16 ]

Locations (26)

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