Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07414550
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.
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.
Study:
NCT07414550
Study Brief:
Protocol Section:
NCT07414550