1726-nm laser treatment for hidradenitis suppurativa (acne inversa)

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

This will test whether a 1726‑nm diode laser can safely reduce painful inflammatory lesions in adults with mild-to-moderate (Hurley I–II) hidradenitis suppurativa by treating one side of the body while the other side receives a sham procedure.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Wynn Medical Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Rosemead, California)
• Trial ID: NCT07155239 on ClinicalTrials.gov

What this trial studies

Adults with bilateral Hurley I–II HS will be randomized in a within-person design so one side receives active 1726‑nm diode laser treatment (AviClear) and the opposite side receives a sham procedure. Participants will undergo three treatment sessions over eight weeks and be followed through Week 24 while remaining on stable HS medications. The primary outcome measures percent change in inflammatory lesion burden from baseline, and an optional translational cohort offers paired 4‑mm punch biopsies at baseline and Week 16. The device targets sebaceous structures in the hair follicle, building on prior laser hair‑removal platforms that reduced HS lesions in controlled trials.

Who should consider this trial

Good fit: Adults 18–60 with clinician-confirmed Hurley stage I–II HS who have paired bilateral inflammatory nodules in eligible regions (axilla, groin, inframammary, inner thigh, or buttock) and can attend in-person visits and avoid new local HS procedures during the study are ideal candidates.

Not a fit: People with extensive Hurley III disease, those without paired bilateral lesions, or those who recently had device/procedure treatments in the target areas are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the laser could meaningfully reduce nodules, abscesses, and flare frequency in people with mild-to-moderate HS, improving pain and quality of life.

How similar studies have performed: Previous randomized trials of follicle-targeting lasers (for example, long‑pulsed 1064‑nm Nd:YAG and 755‑nm alexandrite) demonstrated meaningful reductions in HS lesion counts, supporting the follicular-targeting approach though the 1726‑nm diode has less direct clinical data.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Rosemead, California

• Wynn Medical Center Rheumatology/Dermatology — Rosemead, California, United States (Recruiting)

Study contacts

• Principal investigator: Huynh Wynn Tran CEO/Founder, MD FACP — Wynn Medical Center Research and Education Institute
• Study coordinator: Molynna Nguyen Clinical Research Manager, BS, MA

Conditions Hidradenitis Suppurativa; hidradenitis suppurative; inversa acne