1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

NCT07155239 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: WMCREILAS082025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Keywords

hidradenitis suppurative; inversa acne

Outcome Measures

Primary Outcomes (2)

• Percent change from HS baseline

  Percent change in abscess and inflammatory nodule (AN) count from baseline on the treated side versus the sham side (split-body comparison). HiSCR25 is defined as ≥25% reduction in AN count from baseline, with no increase in abscesses or draining fistulas.

  16 weeks

• Change in pain

  Change in pain as measured by the Visual Analogue Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain

  16 weeks

Secondary Outcomes (1)

• Change in depression scale

  16 weeks

Study Arms (2)

Control Arm

SHAM COMPARATOR

handpiece contact, no cooling, no energy

Device: Sham (No Treatment)

Laser Treatment

EXPERIMENTAL

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

Device: AviClear Lase Treatment

Interventions

AviClear Lase Treatment DEVICE

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

Laser Treatment

Sham (No Treatment) DEVICE

No active laser treatment

Control Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wynn Medical Center: lead

Study Sites (1)

Wynn Medical Center Rheumatology/Dermatology

Rosemead, California, 91770, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Huynh Wynn Tran CEO/Founder, MD FACP

  Wynn Medical Center Research and Education Institute

  PRINCIPAL INVESTIGATOR

• Molynna Nguyen Clinical Research Manager, BS

  Wynn Medical Center Research and Education Institute

  STUDY DIRECTOR

Central Study Contacts

Molynna Nguyen Clinical Research Manager, BS, MA

CONTACT

626 316 8287; molynna.nguyen@wynnmedcenter.com

Huynh W Tran MD CEO/Founder, MD FACP

CONTACT

huynh.tran@wynnmedcenter.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO/Founder

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: September 15, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 08/2025 to 12/2026
• Access Criteria: similar studies and prior approval from our institution

Locations

US (1)