Radiotherapy for Refractory Hidradenitis Suppurativa

NCT07414550 | Recruiting

• 1 other identifier: TJUH-RADIANT-SUPPoRT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Hidradenitis suppurativa; HS; Radiotherapy; Radiation; Treatment resistant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Dermatology Life Quality Index (DLQI)

  Baseline, 4 weeks post-radiotherapy, and 12 weeks post-radiotherapy

• Pain and Symptom Burden (Numerical Rating Scale)

  Baseline, 4 weeks post-radiotherapy, and 12 weeks post-radiotherapy

• Duration Without HS Flare

  Up to 2 years post-radiotherapy (chart review)

• Radiation-Related Toxicities

  During radiotherapy and through 12 weeks post-treatment

• Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score

  Baseline (within 1 week of first radiotherapy treatment) and 4 weeks after completion of radiotherapy

Study Arms (2)

Radiation axilla

EXPERIMENTAL

Participants will receive radiotherapy to one axilla affected by hidradenitis suppurativa.

Radiation: Radiated axilla

Non-radiated Axilla

NO INTERVENTION

The contralateral axilla will not receive radiotherapy and will continue on the current standard of care.

Interventions

Radiated axilla RADIATION

Intervention: Radiation Total dose: 45 Gy Fractionation: 3 Gy per fraction Schedule: Three fractions per week for approximately five weeks

Radiation axilla

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (2)

Jefferson Cherry Hill - Radiation Oncology

Cherry Hill, New Jersey, 08003, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Gregory Alexander, MD

CONTACT

856-922-4800; gregory.alexander@jefferson.edu

Sherry Yang, MD

CONTACT

215-955-6680; Sherry.Yang@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Within Participant (Split-Body Design)

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (2)