20 Participants Needed

Ruxolitinib Cream for Discoid Lupus

Recruiting at 1 trial location
FC
Overseen ByFareheen Chowdhury
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

While there is no direct data on Ruxolitinib cream for discoid lupus, similar treatments like tacrolimus ointment have shown effectiveness in managing symptoms of discoid lupus erythematosus, suggesting that topical treatments can be beneficial.12345

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?

Ruxolitinib cream has been used safely in humans for conditions like atopic dermatitis and vitiligo. Common side effects include mild skin reactions like itching or redness, and it has a favorable safety profile compared to oral versions of the drug.678910

Is Ruxolitinib 1.5% Cream a promising drug for Discoid Lupus?

Ruxolitinib 1.5% Cream has shown promising results in treating skin conditions like atopic dermatitis and cutaneous lichen planus by reducing symptoms and improving skin condition. This suggests it could be a promising option for Discoid Lupus as well.69111213

How is Ruxolitinib cream different from other drugs for discoid lupus?

Ruxolitinib cream is unique because it is a topical treatment that specifically targets Janus kinase (JAK) 1 and JAK2, which are involved in inflammation. This mechanism is different from traditional treatments like corticosteroids, offering a new approach for conditions like discoid lupus.69111213

Research Team

RB

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

I am a woman who can have children and have tested negative for pregnancy.
I am willing and able to give my consent to participate in the study.
Subjects must be willing to comply with all study procedures and must be available for the duration of the study
See 2 more

Exclusion Criteria

Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening
Subject is known to have immune deficiency or is immunocompromised
Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply ruxolitinib 1.5% cream twice daily on active lesions for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ruxolitinib 1.5% Cream
Trial Overview The study tests the effectiveness of Ruxolitinib 1.5% cream in treating discoid lupus erythematosus. It's a single-blind study where participants use the cream normally on some lesions and under occlusion (covered) at night on others to compare results.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: ruxolitinib 1.5% cream (Sequence 1)Experimental Treatment3 Interventions
ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
Group II: ruxolitinib 1.5% cream ( Sequence 2)Experimental Treatment3 Interventions
ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2

Ruxolitinib 1.5% Cream is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Opzelura for:
  • Atopic dermatitis
  • Nonsegmental vitiligo
🇪🇺
Approved in European Union as Opzelura for:
  • Atopic dermatitis
  • Nonsegmental vitiligo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Innovaderm Research Inc.

Lead Sponsor

Trials
49
Recruited
3,200+

Findings from Research

An open-label phase 2 pilot study evaluated the efficacy of oral tofacitinib in treating adult patients with Discoid Lupus Erythematosus (DLE), indicating its potential as a therapeutic option for this condition.
The study suggests that tofacitinib may improve skin lesions associated with DLE, although further research is needed to confirm its safety and effectiveness in larger populations.
Open-Label Phase 2 Pilot Study of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE).Alsukait, S., Learned, C., Rosmarin, D.[2023]
In a study involving 38 patients with cutaneous lupus erythematosus (CLE), topical calcineurin inhibitors (tacrolimus and pimecrolimus) significantly improved clinical symptoms like erythema, desquamation, and edema over 60 days, whether used alone or with hydroxychloroquine.
The combination treatment with hydroxychloroquine led to a 100% improvement in edema among patients, while monotherapy with calcineurin inhibitors resulted in a 75% improvement, highlighting their effectiveness in enhancing treatment outcomes.
Effectiveness of topical calcineurin inhibitors as monotherapy or in combination with hydroxychloroquine in cutaneous lupus erythematosus.Avgerinou, G., Papafragkaki, DK., Nasiopoulou, A., et al.[2014]
In a case study of two patients with severe discoid lupus erythematosus (DLE) resistant to standard treatments, low-dose lenalidomide (5 mg/d) led to significant clinical improvement in one patient within one month, which was sustained for 10 months before dosage adjustment.
While lenalidomide shows promise as an alternative treatment for refractory DLE, it can cause mild neutropenia, necessitating careful monitoring of blood cell counts, and its efficacy was not observed in the second patient, highlighting the need for further research.
Lenalidomide for the treatment of resistant discoid lupus erythematosus.Shah, A., Albrecht, J., Bonilla-Martinez, Z., et al.[2021]

References

Open-Label Phase 2 Pilot Study of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE). [2023]
Effectiveness of topical calcineurin inhibitors as monotherapy or in combination with hydroxychloroquine in cutaneous lupus erythematosus. [2014]
Lenalidomide for the treatment of resistant discoid lupus erythematosus. [2021]
Tacrolimus 0.03% ointment in labial discoid lupus erythematosus: A randomized, controlled clinical trial. [2015]
Rapamycin for refractory discoid lupus erythematosus. [2019]
Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. [2023]
New Indication for Topical Ruxolitnib. [2023]
Utilization of Topical Ruxolitinib in Dermatology: A Review. [2023]
Ruxolitinib Cream in the Treatment of Cutaneous Lichen Planus: A Prospective, Open-Label Study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Review of Ruxolitinib in the Treatment of Atopic Dermatitis. [2023]
Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. [2023]
A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. [2022]
Clinically relevant improvements in adults and adolescents with atopic dermatitis who did not achieve Investigator's Global Assessment treatment success following 8 weeks of ruxolitinib cream monotherapy. [2023]
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