NCT05593432

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

A Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cutaneous Lichen Planus

Interventions

Type	Name	Description
DRUG	Ruxolitinib cream	Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
DRUG	Vehicle cream	Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Timeline

• Start date: 2022-11-23
• Primary completion: 2023-10-02
• Completion: 2024-02-26
• First posted: 2022-10-25
• Last updated: 2024-10-24
• Results posted: 2024-10-24

Locations

24 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study