NCT05593445

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

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.

Conditions

• Lichen Sclerosus

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: 2022-11-18
• Primary completion: 2023-09-01
• Completion: 2023-12-21
• First posted: 2022-10-25
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

14 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study