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 : September 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Drug: 23.4% Hypertonic saline Drug: Saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||September 2021|
|Estimated Study Completion Date :||September 2021|
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.
Other Name: 0.9% sodium chloride
- 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.
- 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.
- 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.
- 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.
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
|Contact: Martina Porter, MD||(617) firstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Martina Porter, MD 617-667-3753 email@example.com|
|Principal Investigator: Alexandra Kimball, MD|
|Principal Investigator:||Maria Palli, MD||Massachusetts General Hospital|