Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805595
• Other study ID #: 2016P001274
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: November 2022

Study information

• Verified date: January 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• 23.4% Hypertonic saline
Saline Injections

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Length of fistula	Measuring the length and the lumen of the fistulas using ultrasound if possible.	Baseline and visit 8
Secondary	Dermatology Life Quality Index	Mean score patient-reported outcomes based on Dermatology Life Quality Index (DLQI).	Baseline to Visit 8
Secondary	HS Patient Local Improvement assessment	Percentage change in Patient improvement assessment about state of the disease over the last 24hours.	Baseline to Visit 8