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1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

NCT07155239 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-17

No results posted yet for this study

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)

Interventions

DEVICE

AviClear Lase Treatment

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

DEVICE

Sham (No Treatment)

No active laser treatment

Sponsors & Collaborators

  • Wynn Medical Center

    lead OTHER

Principal Investigators

  • Huynh Wynn Tran CEO/Founder, MD FACP · Wynn Medical Center Research and Education Institute

  • Molynna Nguyen Clinical Research Manager, BS · Wynn Medical Center Research and Education Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-01-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07155239 on ClinicalTrials.gov