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 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: * 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

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

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)

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 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

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)