CompletedPhase 2

Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

United States21 participantsStarted 2016-08

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HS Physician Local Improvement Assessment - PAIN

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Fluid Leakage From Fistula

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Erythema

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Tenderness

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Swelling

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Hardness of Skin

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Hotness of Skin

Timeframe: Baseline and Visit 4 (week 8)

Trial details

NCT IDNCT02805595

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11

Results submitted2024-08-21

View on ClinicalTrials.gov More Hidradenitis Suppurativa trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

HS Physician Local Improvement Assessment - PAIN

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Fluid Leakage From Fistula

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Erythema

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Tenderness

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Swelling

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Hardness of Skin

Timeframe: Baseline and Visit 4 (week 8)

HS Physician Local Improvement Assessment - Hotness of Skin

Timeframe: Baseline and Visit 4 (week 8)