NCT07155239 · Wynn Medical Center
1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)
(WMCREI)
What this study 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.
View original scientific 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. 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Rosemead, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2025 · Source of record for eligibility and locations