Radiotherapy for Refractory Hidradenitis Suppurativa

N/ANot Yet RecruitingNCT07414550

Thomas Jefferson University10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: Baseline, 4 weeks post-radiotherapy, and 12 weeks post-radiotherapy

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Radiotherapy for Refractory Hidradenitis Suppurativa

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts