Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa

NCT03040804 | Terminated Results DMC FDA Device

• 1 other identifier: 2016-7228
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hidradenitis Suppurativa; Hidradenitis

Keywords

hidradenitis suppurativa; HS; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  Number of participants with HS who experience treatment-related CTCAE version 4.0 Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion. Common Terminology Criteria for Adverse Events (CTCAE) is an internationally accepted standard for defining and categorizing adverse events based on severity of reported adverse events. The grading scheme is from 1 (least severe) to 5 (most severe). For radiotherapy associated adverse events, CTCAE version 4.0 will be applied to "Rash: dermatitis associated with radiation". Grade 1. Mild: Faint erythema or dry desquamation. Grade 2. Moderate: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema. Grade 3. Severe: Moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion. Grade 4. Life threatening: Skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site. Grade 5

  follow up for 3-6 months post treatment

Secondary Outcomes (2)

• Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS).

  6 months - 1 year post treatment

• Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions.

  3-6 months post treatment

Study Arms (1)

Low Dose Radiotherapy

EXPERIMENTAL

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

Radiation: Low dose Radiotherapy

Interventions

Low dose Radiotherapy RADIATION

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.

Also known as: Brachytherapy

Low Dose Radiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women
• Individuals \< 20 years old

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Links

• Montefiore Hidradenitis Suppurativa Multispecialty clinic

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis

Interventions

Radiotherapy; Brachytherapy

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Steven R. Cohen, MD, MPH
• Organization: Montefiore Medical Center

srcohen@montefiore.org

7189208352

Study Officials

• Steven R Cohen, MD, MPH

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Dermatology at Montefiore

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 2, 2017
• Study Start: March 1, 2017
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: November 1, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)