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Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805595
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
Martina Porter, Beth Israel Deaconess Medical Center

Study Description
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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
Hidradenitis Suppurativa Drug: 23.4% Hypertonic saline Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : August 2016
Actual Primary Completion Date : November 2022
Actual Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Drug: 23.4% Hypertonic saline
Saline Injections
Other Name: 23.4% sodium chloride


Outcome Measures
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Primary Outcome Measures :
  1. 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'.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Length of fistula [ Time Frame: Baseline and visit 8 ]
    Measuring the length and the lumen of the fistulas using ultrasound if possible.

  4. Dermatology Life Quality Index [ Time Frame: Baseline to Visit 8 ]
    Mean score patient-reported outcomes based on Dermatology Life Quality Index (DLQI).

  5. HS Patient Local Improvement assessment [ Time Frame: Baseline to Visit 8 ]
    Percentage change in Patient improvement assessment about state of the disease over the last 24hours.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805595


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Martina Porter, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Martina Porter, Instructor in Dermatology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02805595    
Other Study ID Numbers: 2016P001274
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Fistula
Pathological Conditions, Anatomical
Sweat Gland Diseases
Skin Diseases
 Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration