Recruiting
Phase 1

1726-nm Diode Laser

Sponsor:

Wynn Medical Center

Code:

NCT07155239

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

AviClear Lase Treatment

Sham (No Treatment)

Study Details

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.

Conditions

Hidradenitis Suppurativa (HS)

Study ID

NCT07155239

Start date

Sep 15, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Control Arm

handpiece contact, no cooling, no energy

experimental: Laser Treatment

Laser treatment three sessions at Weeks 0, 4, 8; follow-ups at Weeks 12, 16, 24.

Interventions

AviClear Lase Treatment

Three laser sessions at Weeks 0, 4, 8; follow-ups at Weeks 12, 16, 24.

Sham (No Treatment)

No active laser treatment

Primary outcome measure

  • Percent change from HS baseline [ Time Frame: 16 weeks ]
  • Change in pain [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Molynna Nguyen Clinical Research Manager, BS, MA

626 316 8287molynna.nguyen@wynnmedcenter.com

Huynh W Tran MD CEO/Founder, MD FACP

huynh.tran@wynnmedcenter.com

Locations

Wynn Medical Center Rheumatology/Dermatology

Recruiting

Rosemead, California, United States, 91770

More Information

Sponsor

Wynn Medical Center

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

  • hidradenitis suppurative
  • inversa acne

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wynn Medical Center on 2025-09-17.