Study of ruxolitinib cream applied to the skin for people with hidradenitis suppurativa

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What is this study about?

This study focuses on people with Hidradenitis Suppurativa, a chronic skin condition that causes painful bumps to form under the skin, typically in areas where skin rubs together. The research evaluates a medication called ruxolitinib cream, which is applied to the skin twice daily. The cream contains 1.5% of the active ingredient and will be compared to a vehicle cream (a cream without the active medication).

The purpose of this research is to determine how well ruxolitinib cream works in treating mild to moderate Hidradenitis Suppurativa. The study will include people who have had this condition for at least 6 months and have bumps in at least two different body areas. During the study, participants will either use the ruxolitinib cream or the vehicle cream on affected areas of their skin.

The main study period lasts 16 weeks, after which some participants may continue treatment in an extended phase. Throughout the study, participants will need to avoid using certain skin treatments, including antibiotics and antiseptic washes, on the affected areas. Regular check-ups will be conducted to monitor the condition’s response to treatment and ensure participant safety.

1 Initial screening and qualification

During the screening visit, you must be at least 12 years old and have been diagnosed with Hidradenitis Suppurativa (HS) for at least 6 months

Your condition must be mild to moderate, with at least 4 affected areas in at least 2 different body regions (such as underarms, groin folds, or under-breast areas)

You must not have any draining tunnels

2 Treatment period begins

You will receive either ruxolitinib 1.5% cream or a cream without active ingredients (vehicle cream)

The cream needs to be applied to affected areas twice daily

This double-blind period lasts for 16 weeks, meaning neither you nor the study staff will know which cream you are using

3 Treatment restrictions

During the study, you cannot use any antibiotics for HS treatment

You must avoid using antiseptic products on affected areas, including special washes containing chlorhexidine, iodine, bleach, or benzoyl peroxide

Regular soap and water are permitted for cleaning

4 Evaluation period

At week 16, your condition will be evaluated to measure the treatment’s effectiveness

The main goal is to achieve at least 75% reduction in the number of affected areas

Your skin pain levels will be assessed if you had significant pain at the start of the study

5 Extended treatment period

After the initial 16 weeks, the study continues with an open-label extension period

The same treatment restrictions regarding antibiotics and antiseptics continue through week 20 of this extension period

Who Can Join the Study?

  • Must be able to understand and agree to sign a written Informed Consent Form (ICF) for the study
  • Must be 12 years of age or older at the time of screening
  • Must have been diagnosed with Hidradenitis Suppurativa (HS) for at least 6 months before screening, confirmed by a skin specialist
  • Can be either new to treatment or have had previous unsuccessful treatments (excluding basic washes and antiseptics)
  • Must have mild to moderate HS with at least 4 inflamed bumps in at least 2 different body areas (such as underarms, groin folds, or under breast areas), without tunneling wounds
  • Must agree not to use any antibiotic treatments (applied to skin or taken by mouth) for HS during specific periods of the study
  • Must agree not to use antiseptic products (such as chlorhexidine, iodine, bleach, or benzoyl peroxide) on affected areas during specific study periods. Regular soap and water are allowed
  • Must be willing to avoid pregnancy or fathering children during the study period (additional details will be provided)

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • Presence of any active skin infection other than Hidradenitis Suppurativa
  • Current use of systemic immunosuppressive medications (medications that weaken the immune system)
  • History of allergic reactions to similar medications
  • Significant chronic medical conditions that are not well controlled
  • Active or chronic infections such as tuberculosis, hepatitis B, or HIV
  • Major surgery in the past 8 weeks
  • Current participation in other clinical trials
  • Use of other investigational drugs within 30 days before starting this study
  • Severe kidney or liver disease
  • History of skin cancer or other malignancies in the past 5 years
  • Mental conditions that could interfere with study compliance
  • Substance abuse or alcohol dependency within the past 6 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario 12 De Octubre Madrid Spain
AZ Sint-Lucas & Volkskliniek Gent Belgium
Hospital Universitario Virgen De Las Nieves Granada Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hospital General De Granollers Granollers Spain
Hms GmbH Merzig Germany
UNIMED Medical Center EOOD Plovdiv Bulgaria
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Universidade De Santiago De Compostela Santiago De Compostela Spain
EMC Instytut Medyczny S.A. Poznan Poland
Courlancy Sante Reims France
Hautarztpraxis Langenau Langenau Germany
Hautärzte Zentrum Hannover Hanover Germany
Deusxznsom Awk Cqeazcxgmn Ceddje Xobtkdpxjurl Egua Sofia Bulgaria
Tlbhlqlpsdl uwv Sdoqsmolrgg Bveacysr Geua Bad Bentheim Germany
Ahzydiasj Uvh Amsterdam The Netherlands
Efxctwk Uatcntqhaznp Mkcoava Cixifkn Rityfadiq (nisbfsn Mst Rotterdam The Netherlands
Hiftqkuz Dt Lt Sacrw Cftk I Sszr Pqq Barcelona Spain
Ihkwtrhy do Cfoebwkyyxex Hgzixbcpfln Upujtuvxfxobc dx Sfzvs Eixlicq (aacqzsj Saint Priest En Jarez France
Zeqaskr Mwv Swe z owzl Lublin Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
12.09.2025
Bulgaria Bulgaria
Not recruiting
12.09.2025
France France
Not recruiting
12.09.2025
Germany Germany
Not recruiting
12.09.2025
Poland Poland
Not recruiting
12.09.2025
Spain Spain
Not recruiting
12.09.2025
The Netherlands The Netherlands
Not recruiting
12.09.2025

Trial locations

Investigated drugs:

Ruxolitinib cream is a topical medication applied directly to the skin. It belongs to a class of drugs called JAK inhibitors, which work by reducing inflammation in the body. In this trial, it is being studied as a treatment for hidradenitis suppurativa, a chronic inflammatory skin condition that causes painful bumps under the skin. The cream is designed to reduce inflammation and symptoms associated with this condition when applied twice daily to affected areas.

Hidradenitis Suppurativa – A chronic skin condition that causes small, painful lumps to form under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. The condition begins with blockage of hair follicles, leading to inflammation and the development of painful bumps that can grow larger and deeper. These bumps can break open, releasing fluid and potentially connecting with other affected areas to form tunnel-like tracts under the skin. The condition tends to be recurring, with periods of flare-ups and relative calm. Hidradenitis Suppurativa most commonly affects areas with many sweat glands and can cause scarring over time.

Trial ID:
2024-517633-40-00
Protocol code:
INCB018424-325
NCT ID:
NCT06958211
Trial Phase:
Therapeutic confirmatory (Phase III)

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