UnknownEarly Phase 1

Fractional CO2 Laser Fenestration and Steroid Delivery in HS Lesions

10 participantsStarted 2022-11-01

Plain-language summary

Assess the efficacy of fractional ablative CO2 therapy combined with topical steroids in HS patients with Hurley stage I or stage II disease. Hidradenitis suppurativa (HS) is a chronic, oftentimes debilitating inflammatory skin condition that presents with painful lesions in intertriginous areas of the body. The reported prevalence of HS in the U.S. is around 1-4%. Medical therapies, which typically consist of topical or systemic antibiotics, hormone- regulating drugs, and immunomodulators, are initially used to control the disease but HS can be recalcitrant to these modalities in the long-term. Optimizing management of mild-moderate HS is crucial to prevent disease progression and improve patients' quality of life.

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: * 18 years of age or older with a diagnosis of HS for at least 6 months * Subjects who provide informed consent to undergo the procedure * Patients with mild to moderate HS (Hurley stage I or stage II) * Must not have been using topical or systemic therapies for 2 weeks prior to starting treatment on the affected area * The use of antiseptic washes and intralesional steroid injections for acute lesions (rescue therapy) will be allowed Exclusion Criteria: * Under the age of 18 * Pregnant women * Severe HS (Hurley stage III) * Using topical or systemic medications within the 2 weeks prior to starting therapy * History of adverse reactions to laser resurfacing or steroids * Other diseases besides HS which require ongoing systemic therapies * Active infection within the treatment area

What they're measuring

Endpoint Measure of non-inflammatory nodules

Timeframe: After each treatment session (4-6 weeks)

Endpoint measure of Fibrometer measurements

Timeframe: Before and after each treatment session (4-6 weeks)

Endpoint Measure of Elastimeter

Timeframe: Before and after each treatment session (4-6 weeks)

Endpoint measure of self-reported improvement in HS

Timeframe: After each treatment session (4-6 weeks)

Endpoint measure of inflammatory nodules

Timeframe: After each treatment session (4-6 weeks)

Endpoint measure in SkinColorCatch

Timeframe: Before and after each treatment session (4-6 weeks)

Endpoint measure of sinus tracts

Timeframe: After each treatment session (4-6 weeks)

Endpoint measure of abscesses

Timeframe: After each treatment session (4-6 weeks)

Trial details

NCT IDNCT05580029

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-20

Contact for this trial

TIMOTHY J GILLENWATER, MD

323-442-7920 justin.gillenwater@med.usc.edu

View on ClinicalTrials.gov More Scar trials

Plain-language summary

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

Endpoint Measure of non-inflammatory nodules

Timeframe: After each treatment session (4-6 weeks)

Endpoint measure of Fibrometer measurements

Timeframe: Before and after each treatment session (4-6 weeks)

Endpoint Measure of Elastimeter

Timeframe: Before and after each treatment session (4-6 weeks)

Endpoint measure of self-reported improvement in HS

Timeframe: After each treatment session (4-6 weeks)

Endpoint measure of inflammatory nodules

Timeframe: After each treatment session (4-6 weeks)

Endpoint measure in SkinColorCatch

Timeframe: Before and after each treatment session (4-6 weeks)

Endpoint measure of sinus tracts

Timeframe: After each treatment session (4-6 weeks)

Endpoint measure of abscesses

Timeframe: After each treatment session (4-6 weeks)