1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

Part of paid clinical trials in Rosemead, California.

Sponsor
Wynn Medical Center
Study ID
NCT07155239
Phase
PHASE1
Status
Recruiting

Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • AviClear Lase Treatment — DEVICE
    Three laser sessions at Weeks 0, 4, 8; follow-ups at Weeks 12, 16, 24.
  • Sham (No Treatment) — DEVICE
    No active laser treatment

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
Sep 2025
Primary completion
Jan 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percent change from HS baseline [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wynn Medical Center Rheumatology/DermatologyRosemeadCalifornia91770-

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