Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

NCT ID: NCT02805595

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2022-11-30

Brief Summary

This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

Detailed Description

The clinical effect of the hypertonic saline treatment will be evaluated with Physician Assessments at week 2 (t=2), week four (t=4) and week 8 (t=8) and compared with the first visit (baseline) (t=0). If necessary, subjects will be eligible to receive another hypertonic saline injected in week 2 and/or week 4, with a maximum of three injections. Simultaneously improvement will be assessed by ultrasound if possible, using the Philips Lumify Ultrasound Device, and by patients using HS Improvement Assessments. Pain and stinging during treatment sessions will be monitored using numeric rating scales (NRS). For monitoring quality of life the DLQI will be used.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypertonic Saline

23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.

Group Type: EXPERIMENTAL

23.4% Hypertonic saline

Intervention Type: DRUG

Saline Injections

Interventions

23.4% Hypertonic saline

Saline Injections

Intervention Type: DRUG

Other Intervention Names

23.4% sodium chloride

Eligibility Criteria

Inclusion Criteria

• Male or female subjects are at least 18 years of age or older
• A confirmed diagnosis of HS disease
• Presence of inflammatory HS lesion(s) and one or more fistula(s) or sinus tracts

Exclusion Criteria

• Receiving any other kind of treatment for fistulas including introduction of anti-inflammatory systemic therapy such as prednisone or adalimumab within the prior month.
• Are participating in another study using an investigational agent or procedure during participation in this study.
• Are currently pregnant or planning to get pregnant during the study.
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Martina Porter

Instructor in Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martina Porter, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2016P001274

Identifier Type: -

Identifier Source: org_study_id