Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

Beth Israel Deaconess Medical Center (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Anticipated Enrollment :
20 participants
Intervention Model:
Single Group Assignment
Double (Participant, Investigator)
Primary Purpose:
Official Title:
A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa
Actual Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hypertonic Saline

23.4% Hypertonic Saline injection(s) with a maximum of 0.6cc per treatment. If necessary every two weeks, with a maximum of three treatments.

Drug: 23.4% Hypertonic saline
Other Names:
  • 23.4% sodium chloride
  • Placebo Comparator: Saline (Placebo)

    If a patient has two active HS sites with fistulas or sinus tracts, patients will be their own control. Injection with normal saline (placebo) in one site randomly allocated by side. The subject and ultrasound operator will be blinded to the treatment allocation.

    Drug: Saline
    Other Names:
  • 0.9% sodium chloride
  • Outcome Measures

    Primary Outcome Measures

    1. Fistula/Sinus Tract Length [8 weeks]

      The clinical efficacy will be assessed by measuring change in length of the fistulas and/or sinus tracts using ultrasound from baseline at week 8.

    2. Fistula/Sinus Tract Lumen Diameter [8 weeks]

      The clinical efficacy will be assessed by measuring change in diameter of the lumen of the fistulas and/or sinus tracts using ultrasound from baseline at week 8.

    Secondary Outcome Measures

    1. Improvement Assessment [8 weeks]

      This non-validated assessment is based on the Clinical Global Impression (CGI) scale and allows the physician and the subject to score multiple hidradenitis suppurativa (HS) symptoms on a scale from 'extremely worse' to 'very much improved' compared to baseline.

    2. Numeric Rating Scale for Pain/Stinging [1 hour]

      Self-reported pain and stinging intensity during and directly after treatment with Hypertonic saline injections.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    • Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

    Contacts and Locations


    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center


    • Principal Investigator: Martina Porter, MD, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Martina Porter, Instructor in Dermatology, Beth Israel Deaconess Medical Center
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 2016P001274
    First Posted:
    Jun 20, 2016
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2021