Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa (RTHS)
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ClinicalTrials.gov Identifier: NCT03040804 |
Recruitment Status :
Terminated
(Infeasibility to continue study.)
First Posted : February 2, 2017
Last Update Posted : January 15, 2021
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Condition or disease | Intervention/treatment | Phase |
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Hidradenitis Suppurativa Hidradenitis | Radiation: Low dose Radiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Simon two-stage design. In the first stage, 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 and a maximum of 20 patients will be enrolled. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa |
Actual Study Start Date : | March 1, 2017 |
Actual Primary Completion Date : | December 21, 2020 |
Actual Study Completion Date : | December 21, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Low Dose Radiotherapy
Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week
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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.
Other Name: Brachytherapy |
- Number of participants with HS who experience treatment-related Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion, assessed using CTCAE version 4.0 [ Time Frame: follow up for 3-6 months post treatment ]Number of participants with HS who experience treatment-related Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion, assessed using CTCAE version 4.0
- Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS) measures, including pain interference and physical functioning at 3 months (and optionally at 6 months and 12 months) after treatment [ Time Frame: 6 months - 1 year post treatment ]examine the efficacy of radiotherapy in improvement of quality of life
- Evaluation of lesional histological changes associated with radiotherapy using H&E and immunohistochemistry stains on punch biopsy specimens. [ Time Frame: 3-6 months post treatment ]Explore histological changes following radiotherapy for advanced hidradenitits suppurativa

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040804
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Steven R Cohen, MD, MPH | Montefiore Medical Center |
Responsible Party: | Steven R Cohen, Chief of Dermatology at Montefiore, Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT03040804 |
Other Study ID Numbers: |
2016-7228 |
First Posted: | February 2, 2017 Key Record Dates |
Last Update Posted: | January 15, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
hidradenitis suppurativa HS radiotherapy |
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Skin Diseases, Infectious Infection Suppuration |