Radiotherapy for Hidradenitis Suppurativa

(RADIANTSUPPoRT Trial)

Recruiting at 1 trial location

Overseen By Sherry Yang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must be taking: Topical, Systemic HS medications

Disqualifiers: Pregnancy, Severe autoimmune, Poorly controlled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if high-dose radiotherapy can provide lasting relief for people with moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps and sores. Researchers will compare the effects of radiotherapy on one armpit (axilla) while the other receives regular treatment. Participants should have previously tried other treatments without success and have the condition in both armpits.

As an unphased trial, this study offers a unique opportunity to explore a new treatment approach for those seeking alternatives.

Do I have to stop taking my current medications for the trial?

No, you can continue taking your current medications for hidradenitis suppurativa during the trial as part of your standard treatment.

What prior data suggests that radiotherapy is safe for treating hidradenitis suppurativa?

Research has shown that radiotherapy is generally safe for treating hidradenitis suppurativa (HS), particularly in severe cases unresponsive to other treatments. One review suggested that radiotherapy should be considered for patients with difficult-to-treat HS. Another study highlighted increasing evidence supporting its use, indicating it is both safe and effective. A review of published studies also supported these findings, discussing treatment plans and manageable side effects.

Overall, the data suggest radiotherapy is well-tolerated, with most studies noting its safety for HS. However, like any treatment, some side effects may occur, so discussing potential risks with the study team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Radiotherapy for hidradenitis suppurativa is unique because it offers a new approach by specifically targeting the affected area with radiation, which is not the case with typical treatments like antibiotics, anti-inflammatory drugs, or surgical interventions. Unlike current options that often address symptoms indirectly, radiotherapy directly targets the problematic tissue in the axilla. Researchers are excited about this treatment because it could potentially provide a more direct and effective way to manage the condition by reducing inflammation and promoting healing in the specific area, which might lead to better outcomes for patients.

What evidence suggests that radiotherapy might be an effective treatment for hidradenitis suppurativa?

Research has shown that radiotherapy might be a promising treatment for hidradenitis suppurativa (HS), especially in difficult cases. One study found that 19 out of 25 skin problems improved after low-dose radiotherapy. Another report indicated that radiotherapy helped many HS patients feel better and experience less pain. Various studies suggest that this treatment can reduce skin damage and symptoms in affected areas. In this trial, participants will receive radiotherapy to one axilla affected by HS, while the contralateral axilla will not receive radiotherapy and will continue with the current standard of care. Safety data indicate that side effects are usually temporary, making radiotherapy a viable option for those with severe HS. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults (18+) of any gender who have moderate to severe hidradenitis suppurativa affecting both armpits equally, and who haven't responded well to standard treatments. Participants must be able to give informed consent.

Inclusion Criteria

I am willing and able to give my consent to join the study.

I am 18 or older with moderate or severe HS in both armpits.

I have been taking HS medication for at least 1 month and will keep using it during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Evaluation

Participants attend a baseline dermatology skin evaluation, complete multiple surveys, and may participate in an optional biopsy

1 week

1 visit (in-person)

Radiotherapy Treatment

Participants receive radiotherapy to one axilla, delivered to a total dose of 45 Gy in 15 fractions over approximately five weeks

5 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including dermatologic assessments and patient-reported outcomes

12 weeks

2 visits (in-person)

Long-term Follow-up

Long-term safety and disease outcomes assessed by chart review

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Radiotherapy

Trial Overview

The study tests if high-dose radiotherapy on one armpit can reduce symptoms like nodules and abscesses in people with treatment-resistant HS, compared to the other armpit which gets usual care. Each participant serves as their own control.

How Is the Trial Designed?

Group I: Radiation axilla Experimental Treatment 1 Intervention

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

Group II: Non-radiated Axilla Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8984133/

Radiation therapy in chronic hidradenitis suppurativa - PMC

Our case report study showed a good outcome using photon beam radiation therapy in hidradenitis suppurativa. An early response was observed in the third ...

2.

redjournal.org

redjournal.org/article/S0360-3016(25)03690-9/fulltext

Low Dose Radiotherapy in Treatment of Recalcitrant ...

In this heavily pretreated retrospective cohort, low doses of radiotherapy demonstrated high response rates with 19/25 of treated lesions demonstrating a ...

3.

mdpi.com

mdpi.com/2077-0383/15/8/3164

Revisiting Radiotherapy for Hidradenitis Suppurativa

Results: The reviewed studies highlighted a growing body of evidence supporting the use of radiotherapy for HS, especially in severe or treatment-resistant ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301625036909

Low Dose Radiotherapy in Treatment of Recalcitrant ...

Conclusion. In this heavily pretreated retrospective cohort, low doses of radiotherapy demonstrated high response rates with 19/25 of treated lesions ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03040804

Study Details | NCT03040804 | Low Dose Radiotherapy for ...

Evaluation of the efficacy of radiotherapy in improvement of patient's quality of life using patient reported outcome measures, including pain interference and ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38795173/

Efficacy and safety of radiofrequency in the ... - PubMed

Conclusion: RF is a safe energy-based method with promising outcomes, especially for long-term application in mild-to-moderate HS. In moderate- ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1879850025000128

Radiation Therapy in the Management of Hidradenitis ...

RT is a safe and effective treatment option that should be considered for patients with recalcitrant HS.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33535201/

Radiotherapy for Hidradenitis Suppurativa: A Systematic ...

Summary: This systematic review of the published literature reports the patient demographics, treatment regimens, efficacy, and adverse effects ...