Topical Ruxolitinib Cream for Hidradenitis Suppurativa
Trial Summary
Will I have to stop taking my current medications?
You may need to stop some medications, but others can be continued if they have been at a stable dose for a certain period. For example, biologic medications can be continued if stable for 6 months, oral antibiotics for 28 days, hormone-based therapy for 4 months, and oral retinoids for 90 days. However, other topical therapies must be stopped 14 days before the study starts.
What data supports the effectiveness of the drug Ruxolitinib 1.5% Cream for treating hidradenitis suppurativa?
Ruxolitinib cream has shown effectiveness in treating atopic dermatitis, a skin condition, by reducing itchiness and improving skin condition. While it hasn't been specifically studied for hidradenitis suppurativa, its success in treating similar inflammatory skin conditions suggests it might be beneficial.12345
Is topical Ruxolitinib cream safe for use in humans?
Topical Ruxolitinib cream has been well tolerated in studies for conditions like atopic dermatitis, with a safety profile similar to a placebo cream and only infrequent mild skin reactions like stinging or burning. It has minimal absorption into the body, which supports its safety compared to oral forms of the medication.23567
How is Ruxolitinib cream different from other drugs for hidradenitis suppurativa?
Ruxolitinib cream is unique because it is a topical treatment, meaning it is applied directly to the skin, unlike other drugs for hidradenitis suppurativa that are usually injected or taken orally. This cream works by targeting specific pathways involved in inflammation, potentially offering a new approach for managing this condition.1891011
What is the purpose of this trial?
Investigators hypothesize that ruxolitinib 1.5% cream is an effective therapy for HS participants through inhibition of inflammatory activity.Investigators aim to:* Demonstrate the clinical efficacy of ruxolitinib 1.5% cream in decreasing the clinical disease activity after 16 weeks of treatment.* Investigate the impact of ruxolitinib 1.5% cream on skin inflammation through translational analyses of skin biopsy samples.
Eligibility Criteria
This trial is for individuals aged 12 or older with Hidradenitis Suppurativa (HS), specifically Hurley Stage I or II. Participants must have active HS lesions in at least one area, a minimum of 3 inflammatory lesions, and a diagnosis of HS for at least 3 months. They should not have other skin conditions that could affect the study, be pregnant or lactating, and must agree to use contraception during the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive topical Ruxolitinib 1.5% cream, twice daily for 16 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?
Milton S. Hershey Medical Center
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School