Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

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.

Official Title
-----------------
A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Drug: 23.4% Hypertonic saline


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertonic Saline<br>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<br>* Saline Injections<br>* Other names: 23.4% sodium chloride;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HS Physician Local Improvement assessment | 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 | Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections. | Baseline and visit 8 | 
| Numeric Rating Scale for Pain | Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections. | Baseline and visit 8 | 
| Length of fistula | Measuring the length and the lumen of the fistulas using ultrasound if possible. | Baseline and visit 8 | 
| Dermatology Life Quality Index | Mean score patient-reported outcomes based on Dermatology Life Quality Index (DLQI). | Baseline to Visit 8 | 
| HS Patient Local Improvement assessment | Percentage change in Patient improvement assessment about state of the disease over the last 24hours. | Baseline to Visit 8 |