Radiotherapy for Refractory Hidradenitis Suppurativa
ConditionHidradenitis Suppurativa (HS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Radiated axilla
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov