Actively Recruiting
1726-nm Laser (AviClear) for Hidradenitis Suppurativa (HS): A Randomized Split-Body, Sham-Controlled Pilot Trial
Led by Wynn Medical Center · Updated on 2025-09-17
30
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
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 laser's 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.
CONDITIONS
Brief Title
1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years, any sex, Fitzpatrick skin types I-VI
- Clinical diagnosis of Hidradenitis Suppurativa at Hurley stage I or II confirmed by investigator
- At least one inflammatory nodule in a paired, bilateral area (axilla, groin/inguinal, inframammary, inner thigh, or buttock) within 4 weeks prior to baseline
- Able to read and speak English, Chinese, Spanish, or Vietnamese and able to provide signed consent
- Willing and able to comply with study visits, pre/post care, and standardized photography
- Agree to avoid new HS procedures or therapies in study areas through Week 24
- No contraindications to laser treatment and agree to shave or clip hair before treatments
- Optional: willing to undergo 4-mm punch biopsy at baseline and Week 16 with separate consent
You will not qualify if you...
- Hurley stage III disease with extensive sinus tracts
- No qualifying inflammatory nodules in paired bilateral areas in the past 4 weeks
- Device or procedure targeting study areas within 3 months prior (chemical peel, dermabrasion, microneedling/radiofrequency, other lasers, light-based therapies, cryo/chemo-destruction)
- Botulinum toxin use in target areas within 3 months or planned during study
- Systemic retinoid use (e.g., isotretinoin) within 3 months
- Use of photosensitizing medications that increase risk and cannot be paused
- Pregnancy, breastfeeding, or plans to conceive during the study
- Active infection or healing wounds in target areas as judged by investigator
- History of keloids or hypertrophic scars, prior radiation to target areas, malignancy in target areas
- Diagnosed immunodeficiency, uncontrolled coagulation disorder, or use of therapeutic anticoagulation that cannot be safely managed
- Excessive tanning or inability to avoid tanning during study
- Any medical or mental condition or prisoner status that compromises safety or adherence per investigator judgement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive three laser sessions targeting affected areas at Weeks 0, 4, and 8 or a sham treatment without active laser.
3 treatment visits
Duration - 16 weeks
Participants attend follow-up visits to assess treatment effects and safety after the laser or sham sessions.
3 follow-up visits at Weeks 12, 16, and 24
Trial Site Locations
Total: 1 location
1
Wynn Medical Center Rheumatology/Dermatology
Rosemead, California, United States, 91770
Actively Recruiting
Research Team
M
Molynna Nguyen Clinical Research Manager, BS, MA
H
Huynh W Tran MD CEO/Founder, MD FACP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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