RecruitingPhase 1NCT07155239

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

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

Sponsor

Wynn Medical Center

Enrollment

30 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Hidradenitis Suppurativa (HS)

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria8

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).

Exclusion Criteria11

Hurley III (extensive sinus tracts).
No qualifying nodule(s) in paired bilateral regions in past 4 weeks.
Prior device/procedure to target areas within 3 months (chemical peel, dermabrasion, microneedling/RF, other lasers/LBB, cryo/chemo-destruction)
Had Botulinum toxin in target areas within 3 months or planned during study.
Had systemic retinoid (e.g., isotretinoin) within 3 months.
Photosensitizing meds that, in PI's judgment, materially increase risk and cannot be held.
Pregnancy/breastfeeding/plans to conceive during study.
Active infection, still healing wounds (investigator judgment) in target areas.
History of keloids/hypertrophic scars, radiation to target areas, malignancy in target areas, diagnosed immunodeficiency, uncontrolled coagulation disorder or therapeutic anticoagulation that cannot be safely managed.
Excessive tanning or inability to avoid tanning.
Any condition (medical/mental) or prisoner status that in PI's opinion compromises safety or adherence.