Topical Ruxolitinib Cream for Hidradenitis Suppurativa

Phase 2

Recruiting

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Hidradenitis suppurativa, and should be Hurley Stage I or II, defined as papules, nodules, and/or abscess formation, single or multiple, with or without sinus tracts

Negative TB screening assessment (including a PPD test and/or Quantiferon-TB Gold test equivalent) OR for patients with treated latent TB or negative chest x-ray (CXR posterior-anterior [PA] and lateral view within prior 90 days) at Screening with documentation of treated latent tuberculosis (90 days of treatment)

Must not have

Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of HS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a cream containing the drug ruxolitinib can reduce disease activity in people with HS. Investigators will also study how this drug affects inflammation by looking at skin biopsy samples.

Who is the study for?

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.

What is being tested?

The trial tests Ruxolitinib 1.5% cream's effectiveness on HS by reducing inflammation over a period of 16 weeks. It also examines how this topical treatment affects skin inflammation through analysis of biopsy samples from participants.

What are the potential side effects?

Potential side effects are not explicitly listed but may include local reactions like itching or rash where the cream is applied since it targets inflammatory activity in the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Hidradenitis suppurativa at an early or moderate stage.

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I have tested negative for TB or have completed treatment for latent TB.

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I have active skin lesions in at least one area of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active skin conditions that could affect HS assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment. for reporting.