Laser Treatment Using 1726-nm AviClear for Adults with Moderate Hidradenitis Suppurativa Randomized Split-Body Trial Comparing Active Laser to Sham Procedure Phase 1 Study with Follow-up Through Week 24

What this Trial Is About

Hidradenitis suppurativa HS is a long-lasting skin condition causing painful lumps, abscesses, and tunnels near hair follicles, mainly in areas like the armpits and groin. This research evaluates a 1726-nm diode lasers ability to safely reduce inflammatory HS lesions in adults with early-stage Hurley I-II HS by comparing laser treatment to a sham procedure on opposite sides of the body. The study aims to improve understanding of a non-ablative, follicle-targeted laser for managing HS symptoms. Participants will receive three laser treatment sessions over eight weeks, with the active laser applied to one affected side and a sham device on the opposite side. Follow-up visits will occur at Weeks 12, 16, and 24 while participants continue their usual HS medications. The study also offers an optional biopsy for detailed tissue analysis. Participants will be assessed through lesion counts, pain measurements, depression scores, and quality of life evaluations at set intervals. The main outcome is the percentage change in abscess and inflammatory nodules on the treated versus sham side at Week 16. Safety, flare rates, antibiotic use, and patient-reported outcomes will also be monitored throughout the six-month follow-up period.

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)