A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus

Conditions

• Cutaneous Lichen Planus

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 cream — DRUG
  Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Study Details

The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.

Key Dates

Start date

Nov 23, 2022

Status verified

Aug 2024

Primary completion

Oct 2, 2023

Completion

Feb 26, 2024

Study Design

Enrollment

64 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib cream
  Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.
• Placebo Comparator: Vehicle Cream
  Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.

Primary Outcome Measure

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

Locations (22)

Find similar trials in Birmingham, AL