1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

Trial details

Who runs it

Wynn Medical Center

Trial code

NCT07155239

Record updated

17 September 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: Prior device/procedure to target areas within 3 months (chemical peel, dermabrasion, microneedling/RF, other lasers/LBB, cryo/chemo-destruction); 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; Any condition (medical/mental) or prisoner status that in PI's opinion compromises safety or adherence; Hurley III (extensive sinus tracts); No qualifying nodule(s) in paired bilateral regions in past 4 weeks; 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; Excessive tanning or inability to avoid tanning.

ClinicalTrials.gov NCT07155239