Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Hidradenitis Suppurativa
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis suppurativa, skin disease, ruxolitinb cream
Eligibility Criteria
Inclusion Criteria: Diagnosis of HS based on clinical history and physical examination for at least 3 months. Diagnosis of HS (Hurley I or II) with the following: A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND The AN count at the screening AND baseline visits: AN of 3 should affect at least 1 distinct anatomical area AN of > 3 to ≤ 10 should affect at least 2 distinct anatomical areas. Baseline Skin Pain or Itch NRS score ≥ 1. Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study. Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study. Willingness to avoid pregnancy or fathering children Exclusion Criteria: Presence of draining tunnels at screening or at baseline visits. Concurrent conditions and history of other diseases: Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of HS AN or compromise participant safety. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome). Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, or impetigo) within 2 weeks before baseline. Laboratory values outside of the protocol-defined criteria. Use of any prohibited medications per protocol-defined criteria. Pregnant or lactating participants, or those considering pregnancy during the period of their study participation. Other exclusion criteria may apply.
Sites / Locations
- Medical Dermatology Specialists Phoenix
- First Oc Dermatology
- Skin Care Research, Llc Scr Hollywood
- Forcare Clinical Research
- Marietta Dermatology the Skin Cancer Center Marietta
- Delricht Research
- Delricht Research
- Beth Israel Deaconess Medical Center
- Revival Research Institute, Llc Troy
- Dr Bobby Buka, Md Greenwich Village
- Dermatology Associates of Plymouth Meeting
- International Clinical Research Tennessee Llc
- Austin Institute For Clinical Research Aicr Pflugerville
- Progressive Clinical Research
- Dermatology Specialists of Spokane
- Wiseman Dermatology Research Inc
- Dr.Wei Jing Loo Medicine Professional Corp
- Lynderm Research Inc
- Skin Centre For Dermatology
- Xlr8 Medical Research
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Ruxolitinib Cream
Vehicle Cream
Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.