Radiotherapy for Moderate to Severe Hidradenitis Suppurativa in the Axilla

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, non-randomized study assigns radiotherapy to one axilla in adults with bilateral axillary HS of comparable severity, using 45 Gy in 15 fractions over about five weeks. The other axilla serves as an untreated within-subject control while patients continue their standard HS therapies. Assessments include lesion counts, physician global assessments, and patient-reported outcomes at baseline, during treatment, and at 4 and 12 weeks post-radiotherapy, with long-term safety and disease outcomes tracked for up to two years; an optional biopsy sub-study may evaluate histologic changes. Eligible participants are adults 18 and older with Hurley stage II/III HS affecting both axillae, with stable ongoing HS treatments allowed. Primary questions focus on changes in inflammatory nodules, abscesses, draining tracts in the treated vs untreated axilla and improvements in quality of life, pain, and symptom burden.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female subjects between the age of 18 or older with moderate or severe HS (Hurley Stage II or III) with bilateral axillary disease of approximately equivalent disease severity will be included.
* Patients on topical and/or systemic HS medications for at least 1 month will continue maintenance treatment throughout the study period as per standard of care.
* Patients willing and able to provide informed consent

Exclusion Criteria:

* Pregnancy - Women of childbearing potential must use trial approved birth control and obtain a negative pregnancy test 7 days prior to radiotherapy CT simulation.
* Severe autoimmune conditions including lupus, scleroderma and mixed connective tissue disease
* Poorly controlled diabetes per physician discretion, HIV, Hepatitis B/C.
* Prior therapeutic radiotherapy.
* Active malignancy.
* Contraindication to radiotherapy as determined by treating radiation oncologist.
* Patients who began new systemic treatment for their HS \<1 month prior to enrollment in trial
* History of photosensitivity disorders or prior radiation sensitization syndromes
* Any contraindication to radiotherapy as determined by the treating radiation oncologist.

Where it's running

• Jefferson Cherry Hill - Radiation Oncology
  Cherry Hill, New Jersey, United States Recruiting
• Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Gregory Alexander, MD
• Email: gregory.alexander@jefferson.edu
• Phone: 856-922-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.