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 range18 Years

SexALL

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.

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)

HS Physician Local Improvement Assessment - Odor

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 range18 Years

SexALL

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)

HS Physician Local Improvement Assessment - Odor

Timeframe: Baseline and Visit 4 (week 8)