Recruiting

Radiotherapy

Sponsor:

Thomas Jefferson University

Code:

NCT07414550

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiated axilla

Study Details

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)

Study ID

NCT07414550

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiation axilla

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

no intervention: Non-radiated Axilla

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

Interventions

Radiated axilla

Intervention: Radiation

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

Primary outcome measure

  • Change in HS Disease Activity [ Time Frame: Baseline (within 7 days prior to first radiotherapy treatment) to 12 weeks after completion of radiotherapy ]

Central Contacts and Locations

Central contacts

Gregory Alexander, MD

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

Sherry Yang, MD

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

Locations

Jefferson Cherry Hill - Radiation Oncology

Recruiting

Cherry Hill, New Jersey, United States, 08003

Contacts

Gregory Alexander, MD

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

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Sherry Yang, MD

215-955-6680sherry.yang@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • Hidradenitis suppurativa
  • HS
  • Radiotherapy
  • Radiation
  • Treatment resistant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-05-15.