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Fractional CO2 Laser Fenestration and Steroid Delivery in HS Lesions

NCT05580029 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-10-14

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Triamcinolone Topical

The treatments will consist of fractional ablative CO2 laser therapies followed by topical application of triamcinolone dosed at 40 mg/ml.

PROCEDURE

Fractional Ablative CO2 Therapy

1st pass: 30-40 mJ at 5% density. 2nd pass: 120 mJ at 1% density

DRUG

EMLA 5% cream

2 g/10cm2 Topical 30 minutes before each fractional ablative CO2 session

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-01-20
Completion
2023-03-01
FDA Drug
Yes
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580029 on ClinicalTrials.gov