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RECRUITING
NCT07155239
PHASE1

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

Sponsor: Wynn Medical Center

View on ClinicalTrials.gov

Summary

Hidradenitis suppurativa (HS) is a long-lasting skin condition that causes painful lumps, abscesses, and tunnels in areas such as the armpits and groin. HS begins around the hair follicle; when the follicle becomes blocked and inflamed, new lesions form. Prior clinical studies of lasers that act on the hair follicle have shown improvement in HS symptoms, and a 1726-nm diode laser-designed to selectively heat oil glands within the follicle-has reduced inflammatory lesions in acne with good tolerability across many skin types. This study will test whether a 1726-nm diode laser can safely reduce inflammatory HS lesions in Hurley stage I-II disease. Adults with bilateral (right/left) affected areas will be randomized so that one side receives active laser treatment and the other side receives a sham procedure. Participants will have three treatment sessions over 8 weeks and follow-up through Week 24 while continuing their stable HS medications. The primary outcome is the percent change in abscess and inflammatory nodule counts on the treated side versus the sham side at Week 16. Secondary outcomes include validated HS responder scores, pain, quality of life, flare rate/antibiotic use, and safety. Results may support a non-ablative, follicle-directed option for early HS.

Official title: 1726-nm Laser (AviClear) for Hidradenitis Suppurativa (HS): A Randomized Split-Body, Sham-Controlled Pilot Trial

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-15

Completion Date

2026-12-31

Last Updated

2025-09-17

Healthy Volunteers

Yes

Interventions

DEVICE

AviClear Lase Treatment

Three laser sessions at Weeks 0, 4, 8; follow-ups at Weeks 12, 16, 24.

DEVICE

Sham (No Treatment)

No active laser treatment

Locations (1)

Wynn Medical Center Rheumatology/Dermatology

Rosemead, California, United States