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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• Adults 18-60 years; any sex; Fitzpatrick I-VI.

• Clinical HS, Hurley I-II (Investigator confirmed).

• At least one inflammatory nodule in a paired, bilateral region (axilla, groin/inguinal, inframammary, inner thigh, or buttock) within 4 weeks prior to baseline.

• Able to read/speak English/Chinese/Spanish/Vietnamese and sign consent.

• Willing/able to comply with visits, pre/post-care, standardized photography.

• Agree to avoid new HS procedures/therapies in study areas through Week 24.

• No laser contraindication; agrees to shave/clip hair before treatments.

• Optional translational cohort: willing to undergo 4-mm punch biopsy at baseline and Week 16 from the randomized regions (separate consent).

Locations
United States
California
Wynn Medical Center Rheumatology/Dermatology
RECRUITING
Rosemead
Contact Information
Primary
Molynna Nguyen Clinical Research Manager, BS, MA
molynna.nguyen@wynnmedcenter.com
626 316 8287
Backup
Huynh W Tran MD CEO/Founder, MD FACP
huynh.tran@wynnmedcenter.com
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Sham_comparator: Control Arm
handpiece contact, no cooling, no energy
Experimental: Laser Treatment
Laser treatment three sessions at Weeks 0, 4, 8; follow-ups at Weeks 12, 16, 24.
Related Therapeutic Areas
Sponsors
Leads: Wynn Medical Center

This content was sourced from clinicaltrials.gov