NCT03040804

Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa

A Phase I Study of Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. Patients will receive radiotherapy treatment over one week and then they will be followed for the next three months.

Detailed description

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.

Conditions

• Hidradenitis Suppurativa
• Hidradenitis

Interventions

Type	Name	Description
RADIATION	Low dose Radiotherapy	Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.

Timeline

• Start date: 2017-03-01
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2017-02-02
• Last updated: 2021-11-01
• Results posted: 2021-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study