NCT06261021

Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus

A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Innovaderm Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

Detailed description

This study is being conducted to evaluate the efficacy, safety and tolerability of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus. Approximately 20 subjects with discoid lupus erythematosus will apply ruxolitinib 1.5% cream, twice daily on active lesions identified at Day 1 and any new lesions that appear, for 24 weeks.

Conditions

• Discoid Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Ruxolitinib 1.5% cream	Topical application of Ruxolitinib 1.5% cream
PROCEDURE	Application without occlusion in Area 1	Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.
PROCEDURE	Application under occlusion at night in Area 2	Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2.
PROCEDURE	Application under occlusion at night in Area 1	Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.
PROCEDURE	Application without occlusion in Area 2	Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.

Timeline

• Start date: 2024-04-19
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2024-02-15
• Last updated: 2025-03-24

Locations

2 sites across 1 country: Canada