What this study is
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.
What's being tested
- AviClear Lase Treatment
Intervention · DEVICE
Three laser sessions at Weeks 0, 4, 8; follow-ups at Weeks 12, 16, 24.
- Sham (No Treatment)
Intervention · DEVICE
No active laser treatment
Study details
- Official title
- 1726-nm Laser (AviClear) for Hidradenitis Suppurativa (HS): A Randomized Split-Body, Sham-Controlled Pilot Trial
- Sponsor
- Wynn Medical Center
- Conditions
- Hidradenitis Suppurativa (HS)
- Enrolling
- 30 people
- Starts
- 2025-09-15
- Est. completion
- 2026-12-31
- Design
- Triple-blind, randomized, crossover, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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).
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWynn Medical Center Rheumatology/Dermatology
Rosemead, California, United States
Recruiting
Study team
Sponsor
Wynn Medical Center
Study ID WMCREILAS082025
Principal investigator
Huynh Wynn Tran CEO/Founder, MD FACP
Wynn Medical Center Research and Education Institute
Study director
Molynna Nguyen Clinical Research Manager, BS
Wynn Medical Center Research and Education Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.