NCT02805595

Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	23.4% Hypertonic saline	Saline Injections

Timeline

• Start date: 2016-08-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2016-06-20
• Last updated: 2025-03-28
• Results posted: 2025-03-28

Locations

1 site across 1 country: United States