- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02805595
Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa
January 6, 2023 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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
21
Phase
- 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
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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 |
Intervention / Treatment |
---|---|
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.
|
Saline Injections
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HS Physician Local Improvement assessment
Time Frame: Baseline and 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'.
|
Baseline and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Rating Scale for Stinging
Time Frame: Baseline and visit 8
|
Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections.
|
Baseline and visit 8
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Numeric Rating Scale for Pain
Time Frame: Baseline and visit 8
|
Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections.
|
Baseline and visit 8
|
Length of fistula
Time Frame: Baseline and visit 8
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Measuring the length and the lumen of the fistulas using ultrasound if possible.
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Baseline and visit 8
|
Dermatology Life Quality Index
Time Frame: Baseline to Visit 8
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Mean score patient-reported outcomes based on Dermatology Life Quality Index (DLQI).
|
Baseline to Visit 8
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HS Patient Local Improvement assessment
Time Frame: Baseline to Visit 8
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Percentage change in Patient improvement assessment about state of the disease over the last 24hours.
|
Baseline to Visit 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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)
August 1, 2016
Primary Completion (Actual)
November 1, 2022
Study Completion (Actual)
November 1, 2022
Study Registration Dates
First Submitted
June 10, 2016
First Submitted That Met QC Criteria
June 15, 2016
First Posted (Estimate)
June 20, 2016
Study Record Updates
Last Update Posted (Estimate)
January 9, 2023
Last Update Submitted That Met QC Criteria
January 6, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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Incyte CorporationRecruitingHidradenitis Suppurativa (HS)United States, Canada, Bulgaria, Italy, Spain, Germany, Poland, France, Australia, Denmark, United Kingdom
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Novartis PharmaceuticalsAvailableHidradenitis Suppurativa (HS)
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AbbVie (prior sponsor, Abbott)CompletedHidradenitis Suppurativa (HS)
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InflaRx GmbHQuintiles, Inc.CompletedHidradenitis Suppurativa (HS)United States, Bulgaria, Canada, Denmark, France, Germany, Greece, Netherlands, Poland
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Incyte CorporationRecruitingHidradenitis Suppurativa (HS)United States, Canada, Czechia, Spain, Germany, Poland, Netherlands, Belgium, France, Greece, Japan, Austria
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Incyte CorporationRecruitingHidradenitis Suppurativa (HS)United States, Austria, Belgium, Canada, Germany, Poland, Spain, Australia, Denmark, France, United Kingdom, Japan, Bulgaria, Netherlands, Czechia, Greece, Italy
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Clinical Trials on 23.4% Hypertonic saline
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-
Regional Hospital HolstebroCompleted
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Aalborg UniversityThe Danish Rheumatism AssociationCompleted
-
Cairo UniversityCompletedOptic Nerve Sheath | Hypertonic SalineEgypt
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Dr. Michael FlavinWithdrawn
-
Nicole HamblettUniversity of Washington; Dartmouth-Hitchcock Medical Center; Cystic Fibrosis...Completed
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Szpital im. Św. Jadwigi ŚląskiejRecruiting