Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

NCT02805595 | Completed Phase 2 Results

• 1 other identifier: 2016P001274
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (8)

• HS Physician Local Improvement Assessment - PAIN

  Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

  Baseline and Visit 4 (week 8)

• HS Physician Local Improvement Assessment - Fluid Leakage From Fistula

  Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

  Baseline and Visit 4 (week 8)

• HS Physician Local Improvement Assessment - Erythema

  Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

  Baseline and Visit 4 (week 8)

• HS Physician Local Improvement Assessment - Tenderness

  Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

  Baseline and Visit 4 (week 8)

• HS Physician Local Improvement Assessment - Swelling

  Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

  Baseline and Visit 4 (week 8)

• HS Physician Local Improvement Assessment - Hardness of Skin

  Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

  Baseline and Visit 4 (week 8)

• HS Physician Local Improvement Assessment - Hotness of Skin

  Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

  Baseline and Visit 4 (week 8)

• HS Physician Local Improvement Assessment - Odor

  Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

  Baseline and Visit 4 (week 8)

Secondary Outcomes (12)

• Numeric Rating Scale for Stinging

  Baseline and visit 4 (week 8)

• Numeric Rating Scale for Pain

  Baseline and visit 4 (week 8)

• Length of Fistula

  Baseline and visit 4 (week 8)

• Dermatology Life Quality Index

  Baseline and visit 4 (week 8)

• HS Patient Local Improvement Assessment - Pain

  Baseline to Visit 4 (week 8)

Study Arms (1)

Hypertonic Saline

EXPERIMENTAL

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.

Drug: 23.4% Hypertonic saline

Interventions

23.4% Hypertonic saline DRUG

Saline Injections

Also known as: 23.4% sodium chloride

Hypertonic Saline

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Saline Solution, Hypertonic; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Study limitations include 1) small sample size and lack of a control group. 2) the lack of an established scoring system for assessing improvement in individual fistulas. 3) We were unable to determine full fistula dimensions over time with ultrasound. 4) This was a single team of clinical investigators; therefore, treatment efficacy cannot be assessed between study investigators who were not trained by the original investigators.

Results Point of Contact

• Title: Martina Porter - Associate Directory of Dermatology Research
• Organization: Beth Israel Deaconess Medical Center

mporter3@bidmc.harvard.edu

6176675834

Study Officials

• Martina Porter, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Dermatology

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 20, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)