Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa

This is a phase I clinical trial using a Simon-two stage design to establish the safety of
radiotherapy in the treatment of advanced hidradenitis suppurativa (HS). In the first six
months, 6 patients will be enrolled, if the patients in the study do not meet the termination
criteria, then the study will extend to a second stage. A maximum of 20 patients will be
enrolled. Patients will be treated with skin-directed radiotherapy, using a total
prescription dose of 7.5 Gy in five fractions of 1.5 Gy over one week. Patients will then be
seen in the HS specialty clinic at Montefiore Medial Center for at least three months.
Quality of life changes, immunohistochemical changes, and cutaneous discharge will also be
evaluated during the study period.

Inclusion Criteria:

- Diagnosis of Hidradenitis Suppurativa made at the Montefiore Hidradenitis Suppurativa
Treatment Center, with Hurley Stage 2-3 (defined as recurrent abscesses or boils with
diffuse or broad involvement, multiple interconnected sinus tracts in the whole area)

- Failed maximal medical therapy for Hidradenitis Suppurativa or ineligible for
"standard" medical therapy or surgery

- Age > 20 years

- Women of childbearing age: must have a negative pregnancy test within 72 hours prior
to the start of study therapy and agree to an adequate method of contraception
throughout treatment and for at least 4 weeks after study contraception.

Exclusion Criteria:

- Pregnant women

- Individuals < 20 years old