Ruxolitinib Cream for Discoid Lupus
Trial Summary
What is the purpose of this trial?
This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
Do I have to stop taking my current medications?
The trial requires that you stop using any topical medicated treatments that could affect discoid lupus erythematosus (DLE) within 2 weeks before starting the study. This includes topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices. Additionally, you must not have received any biological agents within 12 weeks or 5 half-lives before the study. The protocol does not specify other medications, so it's best to discuss with the study team.
Will I have to stop taking my current medications?
The trial requires that you stop using any topical medicated treatments that could affect discoid lupus erythematosus (DLE) within 2 weeks before starting the study. Additionally, you must not have used any biological agents within 12 weeks or certain investigational products within 4 weeks before the study begins.
What data supports the idea that Ruxolitinib Cream for Discoid Lupus is an effective treatment?
The available research does not provide specific data on the effectiveness of Ruxolitinib Cream for Discoid Lupus. However, it mentions other treatments like tacrolimus ointment and rapamycin, which have shown effectiveness in treating Discoid Lupus. Tacrolimus was found to be as effective as another treatment, triamcinolone acetonide, in reducing symptoms, while rapamycin showed a positive response in a case resistant to other treatments. This suggests that while Ruxolitinib Cream's effectiveness isn't directly supported by the data, other similar treatments have shown promise.12345
What data supports the effectiveness of the drug Ruxolitinib cream for treating discoid lupus?
What safety data exists for Ruxolitinib cream?
Ruxolitinib cream, also known as Opzelura, has been evaluated for safety in various dermatological conditions such as atopic dermatitis, vitiligo, psoriasis, and lichen planus. In studies, it was well tolerated with a safety profile similar to vehicle cream, showing minimal bioavailability and low rates of mild-to-moderate treatment-related adverse events. Common adverse effects include application site acne, itching, redness, and systemic effects like headache and fever. No significant systemic JAK inhibition safety concerns were identified.678910
Is Ruxolitinib cream safe for use in humans?
Is Ruxolitinib 1.5% Cream a promising drug for Discoid Lupus?
How is Ruxolitinib cream different from other drugs for discoid lupus?
Research Team
Robert Bissonnette, MD
Principal Investigator
Innovaderm Research Inc.
Eligibility Criteria
This trial is for adults with discoid lupus erythematosus, a chronic skin condition. Participants should have stable disease and be willing to apply cream treatments as directed. Specific eligibility details are not provided, but typically trials exclude those with certain health conditions or who are taking conflicting medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply ruxolitinib 1.5% cream twice daily on active lesions for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ruxolitinib 1.5% Cream
Ruxolitinib 1.5% Cream is already approved in United States, European Union for the following indications:
- Atopic dermatitis
- Nonsegmental vitiligo
- Atopic dermatitis
- Nonsegmental vitiligo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Innovaderm Research Inc.
Lead Sponsor