Actively Recruiting
1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)
Led by Wynn Medical Center · Updated on 2025-09-17
30
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 to VI
- Clinically confirmed hidradenitis suppurativa, Hurley stage I or II
- At least one inflammatory nodule in a paired, bilateral region (axilla, groin/inguinal, inframammary, inner thigh, or buttock) within 4 weeks before baseline
- Able to read/speak English, Chinese, Spanish, or Vietnamese and able to sign informed consent
- Willing and able to comply with study visits, pre- and post-treatment 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 nodules in paired bilateral regions within the past 4 weeks
- Prior device or procedure targeting study areas within 3 months (chemical peel, dermabrasion, microneedling, radiofrequency, other lasers, light-based therapies, cryo- or chemo-destruction)
- Botulinum toxin treatment in target areas within 3 months or planned during the study
- Systemic retinoid use (e.g., isotretinoin) within 3 months
- Use of photosensitizing medications that cannot be safely held
- Pregnancy, breastfeeding, or plans to conceive during the study
- Active infection or healing wounds in target areas judged by the investigator
- History of keloids or hypertrophic scars, radiation to target areas, malignancy in target areas
- Diagnosed immunodeficiency, uncontrolled coagulation disorder, or anticoagulation therapy that cannot be safely managed
- Excessive tanning or inability to avoid tanning
- Any medical, mental, or prisoner status that compromises safety or study adherence per investigator judgment
AI-Screening
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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
CONTACT
H
Huynh W Tran MD CEO/Founder, MD FACP
CONTACT
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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