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

Sponsor
Innovaderm Research Inc.
Study ID
NCT06261021
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Discoid Lupus Erythematosus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Apr 19, 2024
Status verified
Mar 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ruxolitinib 1.5% cream (Sequence 1)
    ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
  • Experimental: ruxolitinib 1.5% cream ( Sequence 2)
    ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2

Primary Outcome Measure

Change from baseline in target lesion CLASI-A score [ Time Frame: Week 24 ]

Central Contacts