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Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
23.4% Hypertonic saline
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
  • 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.

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypertonic Saline

Arm Description

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.

Outcomes

Primary Outcome Measures

HS Physician Local Improvement assessment
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'.

Secondary Outcome Measures

Numeric Rating Scale for Stinging
Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections.
Numeric Rating Scale for Pain
Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections.
Length of fistula
Measuring the length and the lumen of the fistulas using ultrasound if possible.
Dermatology Life Quality Index
Mean score patient-reported outcomes based on Dermatology Life Quality Index (DLQI).
HS Patient Local Improvement assessment
Percentage change in Patient improvement assessment about state of the disease over the last 24hours.

Full Information

First Posted
June 10, 2016
Last Updated
January 6, 2023
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02805595
Brief Title
Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa
Official Title
A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
November 2022 (Actual)
Study Completion Date
November 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertonic Saline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
23.4% Hypertonic saline
Other Intervention Name(s)
23.4% sodium chloride
Intervention Description
Saline Injections
Primary Outcome Measure Information:
Title
HS Physician Local Improvement assessment
Description
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'.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Numeric Rating Scale for Stinging
Description
Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections.
Time Frame
Baseline and visit 8
Title
Numeric Rating Scale for Pain
Description
Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections.
Time Frame
Baseline and visit 8
Title
Length of fistula
Description
Measuring the length and the lumen of the fistulas using ultrasound if possible.
Time Frame
Baseline and visit 8
Title
Dermatology Life Quality Index
Description
Mean score patient-reported outcomes based on Dermatology Life Quality Index (DLQI).
Time Frame
Baseline to Visit 8
Title
HS Patient Local Improvement assessment
Description
Percentage change in Patient improvement assessment about state of the disease over the last 24hours.
Time Frame
Baseline to Visit 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Porter, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

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