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TRuE-HS1 Ruxolitinib Cream Study

TRuE-HS1 Ruxolitinib Cream Study

This study aims to evaluate the safety and effects of a study cream called ruxolitinib compared with a vehicle cream in individuals with Hidradenitis Suppurativa. The vehicle cream, which does not contain the active drug, will be used to help determine whether the study cream provides greater benefits. Ruxolitinib is an investigational cream, which means it has not been approved by the Food and Drug Administration (FDA) for people with HS, but it has been approved for use in people with other skin conditions like atopic dermatitis. Participation will start with a 28-day screening period, followed by 16 weeks of applying the study cream or placebo cream twice a day (this is a double-blind period), with 6 visits over that time period; followed by 36 weeks, with 9 visits over that time period, applying the study cream twice a day (this is an open-label period). There will be a follow up visit 30 days after the last application of study cream. During these visits participants may have a physical exam, blood draw, have skin examined for lesions and those present counted, and asked to fill out a diary, questionnaires and surveys. Participants will also be asked to complete a daily questionnaire, as well as an application diary. Participants could receive compensation for taking part in the study and reimbursement for travel.

Participant Eligibility

• Be at least 12 years old
• Have HS for at least 6 months
• Agree to not use other products or medications for HS

Contact

Camila Marquez
(206) 543-5312

Additional Study Details

Full Study Title
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa: Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)

Study ID: TRuE-HS1 Ruxolitinib Cream Study
Start Date: 12/03/2025
End Date: 12/31/2027

Investigator(s)
Dr. Vivian Shi, Dr. Song Park

Accepts Healthy Volunteers?
No

Study Site(s)

University of Washington, Roosevelt Clinic

4225 Roosevelt Way NE
Seattle, Washington 98105



Interested?

Use the link below to send a message to the study coordinator, or call the number above to speak directly with a study representative.

I am interested in this research study.

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