Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

March 11, 2025 updated by: Martina Porter, Beth Israel Deaconess Medical Center

A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: 23.4% Hypertonic saline
Saline Injections
Other Names:
  • 23.4% sodium chloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HS Physician Local Improvement Assessment - PAIN
Time Frame: Baseline and Visit 4 (week 8)

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
Time Frame: Baseline and Visit 4 (week 8)

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
Time Frame: Baseline and Visit 4 (week 8)

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
Time Frame: Baseline and Visit 4 (week 8)

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
Time Frame: Baseline and Visit 4 (week 8)

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
Time Frame: Baseline and Visit 4 (week 8)

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
Time Frame: Baseline and Visit 4 (week 8)

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
Time Frame: Baseline and Visit 4 (week 8)

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale for Stinging
Time Frame: Baseline and visit 4 (week 8)

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

Pain with a score of 1 (no stinging at all) to 10 (worst possible stinging).
Baseline and visit 4 (week 8)
Numeric Rating Scale for Pain
Time Frame: Baseline and visit 4 (week 8)

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

Pain with a score of 1 (no pain at all) to 10 (worst possible pain).
Baseline and visit 4 (week 8)
Length of Fistula
Time Frame: Baseline and visit 4 (week 8)
Measuring the length and the lumen of the fistulas using ultrasound if possible.
Baseline and visit 4 (week 8)
Dermatology Life Quality Index
Time Frame: Baseline and visit 4 (week 8)

Number of subjects improving based upon patient-reported outcomes The Dermatology Life Quality Index (DLQI) is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment)

The scoring of each question is as follows:

Very much scored = 3 points, A lot scored = 2 points, A little scored = 1, Not at all scored = 0 points, Not relevant scored = 0 points, Question 7, 'prevented work or studying' scored = 3 points. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 (meaning maximum impact on quality of life) and a minimum of 0 (meaning no impact of skin disease on quality of life). The higher the score, the more quality of life is impaired.

0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.
Baseline and visit 4 (week 8)
HS Patient Local Improvement Assessment - Pain
Time Frame: Baseline to Visit 4 (week 8)

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease 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 to Visit 4 (week 8)
HS Patient Local Improvement Assessment - Fluid From Fistula
Time Frame: Baseline and Visit 4 (week 8)

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease 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 Patient Local Improvement Assessment - Erythema
Time Frame: Baseline and Visit 4 (week 8)

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease 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 Patient Local Improvement Assessment - Tenderness
Time Frame: Baseline and Visit 4 (week 8)

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease 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 Patient Local Improvement Assessment - Swelling
Time Frame: Baseline and Visit 4 (week 8)

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease 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 Patient Local Improvement Assessment - Hardness of Skin
Time Frame: Baseline and Visit 4 (week 8)

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease 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 Patient Local Improvement Assessment - Hotness of Skin
Time Frame: Baseline and Visit 4 (week 8)

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease 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 Patient Local Improvement Assessment - Odor
Time Frame: Baseline and Visit 4 (week 8)

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martina Porter, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016P001274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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