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Hidradenitis Suppurativa (HS)RADIANTSUPPoRTNCT07414550

Radiotherapy for Refractory Hidradenitis Suppurativa

A study testing Radiated axilla in people with Hidradenitis Suppurativa (HS), run by Thomas Jefferson University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hidradenitis Suppurativa (HS)
What is being tested?
Radiated axilla
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
1 May 2026to 1 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gregory Alexander, MD contact

856-922-4800

gregory.alexander@jefferson.edu

Sherry Yang, MD contact

215-955-6680

Sherry.Yang@jefferson.edu

United States2 sites, 2 recruiting

  • Jefferson Cherry Hill - Radiation Oncology

    Cherry Hill, New Jersey, 08003

    Gregory Alexander, MD, 856-922-4800, gregory.alexander@jefferson.edu

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Sherry Yang, MD, 215-955-6680, sherry.yang@jefferson.edu

    Recruiting

Other trials in United States

About this study

Official title: 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?

Read more

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.
Read the 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.

Being tested
Radiated axilla
Keywords
Hidradenitis suppurativa, HS, Radiotherapy, Radiation, Treatment resistant
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiated axillaRadiation

    Intervention: Radiation

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

Study groups in NCT07414550
Study groupRoleWhat they receive
Radiation axillaExperimentalParticipants will receive radiotherapy to one axilla affected by hidradenitis suppurativa.
Receives: Radiation: Radiated axilla
Non-radiated AxillaNo interventionThe contralateral axilla will not receive radiotherapy and will continue on the current standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (within 7 days prior to first radiotherapy treatment) to 12 weeks after completion of radiotherapy

Secondary outcomes (7)

  1. 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.

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

  2. 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.

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

  3. 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

    Measured: Up to 2 years post-radiotherapy (chart review)

  4. Radiation-Related Toxicities

    Incidence and grading of radiation-induced toxicities (per CTCAE criteria) will also be assessed as a safety endpoint.

    Measured: During radiotherapy and through 12 weeks post-treatment

  5. 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.

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

  6. Response Rates

    Partial response: ≥1-point decrease in HS-PGA Complete response: ≥2-point decrease in HS-PGA

    Measured: 12 weeks post-radiotherapy

  7. Optional: Histopathological Characterization in Treated Skin

    This outcome will characterize the histopathologic features seen from punch biopsies. Participation in this is optional to participants.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Within Participant (Split-Body Design)
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07414550
Sponsor's protocol ID
TJUH-RADIANT-SUPPoRT
Acronym
RADIANTSUPPoRT
Status last verified
May 2026
First submitted
22 Jan 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiated axilla in people with Hidradenitis Suppurativa (HS), run by Thomas Jefferson University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gregory Alexander, MD (856-922-4800, gregory.alexander@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07414550.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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