Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

Beth Israel Lahey Health

Status and phase

Completed

Phase 2

Conditions

Hidradenitis Suppurativa

Treatments

Drug: 23.4% Hypertonic saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02805595

2016P001274

Details and patient eligibility

About

This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.