Radiotherapy for Refractory Hidradenitis Suppurativa (RADIANTSUPPoRT)

Radiotherapy for Treatment of Recalcitrant Hidradenitis Suppurativa (RADIANT-SUPPoRT)

The goal of this clinical trial is to learn if high-dose radiotherapy can provide sustained disease relief in moderate to severe, treatment resistant Hidradenitis suppurativa patients; could include any of the following: any sex/gender, and those greater then 18 years old. The main question[s] it aims to answer are:

Outcome measure 1: Will radiotherapy change the number of inflammatory nodules, abscesses, and draining sinus tracts in the treated axilla compared with the untreated axilla? Outcome measure 2: Will radiotherapy positively change a patient's quality of life, pain levels and symptom burden?

Participants will receive radiotherapy to one axilla affected by hidradenitis suppurativa. The contralateral axilla will not receive radiotherapy and will continue receiving the standard treatment regimen.

Participants will...

• Attend a baseline dermatology skin evaluation, complete multiple surveys and an optional participation in a biopsy
• Attend multiple radiation sessions over 5 weeks
• Attend 2 follow up visits with dermatology for skin evaluation, complete follow up surveys, and an optional biopsy.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Radiation: Radiated axilla

Detailed Description

This is a prospective, non-randomized, split-body interventional study enrolling adults with moderate to severe hidradenitis suppurativa involving bilateral axillary disease of comparable severity. Each participant will receive radiotherapy to one axilla, while the contralateral axilla will serve as an untreated within-subject control.

Radiotherapy will be delivered to a total dose of 45 Gy in 15 fractions (3 Gy per fraction), administered three times per week over approximately five weeks.

Patients will continue stable background HS therapies during the study period. Dermatologic assessments, lesion counts, physician global assessment scores, and patient-reported outcomes will be collected at baseline, during treatment, and at 4 and 12 weeks following completion of radiotherapy. Long-term safety and disease outcomes will be assessed by chart review for up to two years post-treatment. An optional punch biopsy sub-study will evaluate histologic changes associated with treatment response.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregory Alexander, MD; Phone Number: 856-922-4800; Email: gregory.alexander@jefferson.edu
• Study Contact Backup: Name: Sherry Yang, MD; Phone Number: 215-955-6680; Email: sherry.yang@jefferson.edu

Study Locations

• United States
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Recruiting
      • Jefferson Cherry Hill - Radiation Oncology
      • Contact: Gregory Alexander, MD; Phone Number: 856-922-4800; Email: gregory.alexander@jefferson.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
      • Contact: Sherry Yang, MD; Phone Number: 215-955-6680; Email: sherry.yang@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation axilla; Participants will receive radiotherapy to one axilla affected by hidradenitis suppurativa.	Radiation: Radiated axilla; Intervention: Radiation Total dose: 45 Gy Fractionation: 3 Gy per fraction Schedule: Three fractions per week for approximately five weeks
No Intervention: Non-radiated Axilla; The contralateral axilla will not receive radiotherapy and will continue on the current standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HS Disease Activity	Change in the number of inflammatory nodules, abscesses, and draining sinus tracts in the treated axilla compared with the untreated axilla.	Baseline (within 7 days prior to first radiotherapy treatment) to 12 weeks after completion of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatology Life Quality Index (DLQI)	Change in quality of life as measured by DLQI. A list of 10 questions graded on a likert scale. The mimimum selection is "Not at all" or "No", the maximum selection is "Very much" or "Yes". Depending on the question phrasing the maximum or minimum scores could correlate to a positive or negative outcome.	Baseline, 4 weeks post-radiotherapy, and 12 weeks post-radiotherapy
Pain and Symptom Burden (Numerical Rating Scale)	Patient-reported symptom severity using a numerical rating scale. This is a list of survey questions, with each question having a correlating likert scale. For each question, the lowest score would be 0 and the highest score would be 10. Depending on the question phrasing the maximum or minimum scores could correlate to a positive or negative outcome.	Baseline, 4 weeks post-radiotherapy, and 12 weeks post-radiotherapy
Duration Without HS Flare	Time to disease flare in the treated axilla, defined as increased lesion counts, ≥2-point HS-PGA increase, or initiation of rescue therapy	Up to 2 years post-radiotherapy (chart review)
Radiation-Related Toxicities	Incidence and grading of radiation-induced toxicities (per CTCAE criteria) will also be assessed as a safety endpoint.	During radiotherapy and through 12 weeks post-treatment
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score	Change in HS disease activity, measured by HS-Physician Global Assessment (HS-PGA) score. Minimum score is zero and maximum score is 5. A higher score would indicate a worse outcome.	Baseline (within 1 week of first radiotherapy treatment) and 4 weeks after completion of radiotherapy
Response Rates	Partial response: ≥1-point decrease in HS-PGA Complete response: ≥2-point decrease in HS-PGA	12 weeks post-radiotherapy
Optional: Histopathological Characterization in Treated Skin	This outcome will characterize the histopathologic features seen from punch biopsies. Participation in this is optional to participants.	Baseline and 12 weeks post-radiotherapy biopsies. This is only in the subset of participants that agreed to participate in this arm of the trial.

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Radiotherapy; Treatment resistant; Radiation; Hidradenitis suppurativa; HS
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: TJUH-RADIANT-SUPPoRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No