NCT07155239 1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)
| NCT ID | NCT07155239 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Wynn Medical Center |
| Condition | Hidradenitis Suppurativa (HS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-09-15 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Huynh Wynn Tran CEO/Founder, MD FACP
PRINCIPAL INVESTIGATOR
Wynn Medical Center Research and Education Institute
Frequently Asked Questions
Who can join the NCT07155239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Hidradenitis Suppurativa (HS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07155239 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07155239 currently recruiting?
Yes, NCT07155239 is actively recruiting participants. Contact the research team at molynna.nguyen@wynnmedcenter.com for enrollment information.
Where is the NCT07155239 trial being conducted?
This trial is being conducted at Rosemead, United States.
Who is sponsoring the NCT07155239 clinical trial?
NCT07155239 is sponsored by Wynn Medical Center. The principal investigator is Huynh Wynn Tran CEO/Founder, MD FACP at Wynn Medical Center Research and Education Institute. The trial plans to enroll 30 participants.