Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa
This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.
Arms and Interventions
|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
|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.
Primary Outcome Measures
- Fistula/Sinus Tract Length [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 [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
- Improvement Assessment [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 [1 hour]
Self-reported pain and stinging intensity during and directly after treatment with Hypertonic saline injections.
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
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.
Contacts and Locations
|1||Beth Israel Deaconess Medical Center||Boston||Massachusetts||United States||02215|
Sponsors and Collaborators
- Beth Israel Deaconess Medical Center
- Principal Investigator: Martina Porter, MD, Beth Israel Deaconess Medical Center
Study Documents (Full-Text)None provided.