Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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...
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation axilla | Experimental | Participants will receive radiotherapy to one axilla affected by hidradenitis suppurativa. |
|
| Non-radiated Axilla | No Intervention | The contralateral axilla will not receive radiotherapy and will continue on the current standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiated axilla | Radiation | Intervention: Radiation Total dose: 45 Gy Fractionation: 3 Gy per fraction Schedule: Three fractions per week for approximately five weeks |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory Alexander, MD | Contact | 856-922-4800 | gregory.alexander@jefferson.edu | |
| Sherry Yang, MD | Contact | 215-955-6680 | Sherry.Yang@jefferson.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Cherry Hill - Radiation Oncology | Recruiting | Cherry Hill | New Jersey | 08003 | United States |
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
Within Participant (Split-Body Design)
Not provided
Not provided
Not provided
Not provided
| 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. |
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |