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Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT02805595
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Alexa B Kimball, Beth Israel Deaconess Medical Center

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 Drug: Saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 30, 2019

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Arm Intervention/treatment
Experimental: Hypertonic Saline
23.4% Hypertonic Saline injection(s) with a maximum of 0.6cc per treatment. If necessary every two weeks, with a maximum of three treatments.
Drug: 23.4% Hypertonic saline
Other Name: 23.4% sodium chloride

Placebo Comparator: Saline (Placebo)

If a patient has two active HS sites with fistulas or sinus tracts, patients will be their own control.

Injection with normal saline (placebo) in one site randomly allocated by side. The subject and ultrasound operator will be blinded to the treatment allocation.

Drug: Saline
Other Name: 0.9% sodium chloride




Primary Outcome Measures :
  1. Fistula/Sinus Tract Length [ Time Frame: 8 weeks ]
    The clinical efficacy will be assessed by measuring change in length of the fistulas and/or sinus tracts using ultrasound from baseline at week 8.

  2. Fistula/Sinus Tract Lumen Diameter [ Time Frame: 8 weeks ]
    The clinical efficacy will be assessed by measuring change in diameter of the lumen of the fistulas and/or sinus tracts using ultrasound from baseline at week 8.


Secondary Outcome Measures :
  1. Improvement Assessment [ Time Frame: 8 weeks ]
    This non-validated assessment is based on the Clinical Global Impression (CGI) scale and allows the physician and the subject to score multiple hidradenitis suppurativa (HS) symptoms on a scale from 'extremely worse' to 'very much improved' compared to baseline.

  2. Numeric Rating Scale for Pain/Stinging [ Time Frame: 1 hour ]
    Self-reported pain and stinging intensity during and directly after treatment with Hypertonic saline injections.



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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.
  • Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

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


Contacts
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Contact: Martina Porter, MD (617) 667-3753 mporter3@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Martina Porter, MD    617-667-3753    mporter3@bidmc.harvard.edu   
Principal Investigator: Alexandra Kimball, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Maria Palli, MD Massachusetts General Hospital

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Responsible Party: Alexa B Kimball, Director, CLEARS, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02805595     History of Changes
Other Study ID Numbers: 2016P001274
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Fistula
Hidradenitis
Hidradenitis Suppurativa
Pathological Conditions, Anatomical
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration