Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Radiated axilla

    Radiation

    Intervention: Radiation Total dose: 45 Gy Fractionation: 3 Gy per fraction Schedule: Three fractions per week for approximately five weeks

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Radiation axillaExperimental treatment 1 intervention
Group B: Non-radiated AxillaNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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)
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

Source ClinicalTrials.gov
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