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Hidradenitis Suppurativa (HS)Phase 1WMCREINCT07155239

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

A Phase 1 study testing AviClear Lase Treatment in people with Hidradenitis Suppurativa (HS), run by Wynn Medical Center at 1 site in United States.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hidradenitis Suppurativa (HS)
What is being tested?
AviClear Lase Treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
15 Sep 2025to 31 Dec 2026
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site, 1 recruiting
  • Wynn Medical Center Rheumatology/Dermatology

    Rosemead, California, 91770

    Recruiting

Other trials in United States

About this study

Official title: 1726-nm Laser (AviClear) for Hidradenitis Suppurativa (HS): A Randomized Split-Body, Sham-Controlled Pilot Trial

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.

Read the detailed description

Hidradenitis suppurativa (HS) is a chronic, relapsing inflammatory disorder of the hair follicle characterized by painful nodules, abscesses, and dermal tunnels that cluster in intertriginous sites. Contemporary models place follicular occlusion and rupture of the pilosebaceous unit, rather than primary apocrine disease, at the start of the cascade, with downstream innate/adaptive immune activation (e.g., TNF-α, IL-17/IL-23 axes). This follicle-centric pathogenesis underpins the therapeutic logic for energy-based approaches that target follicular structures to reduce lesion initiation.

Multiple controlled studies show that laser/light devices aimed at the folliculo-sebaceous apparatus can improve HS activity, supporting this mechanistic rationale. In a randomized controlled trial (n=22) of long-pulsed 1064-nm Nd:YAG, three monthly sessions reduced HS severity (modified HS-LASI) by ~65% overall at 3 months in treated vs control sites (p<0.02), with site-specific reductions (inguinal ~73%, axillary ~62%).

As the investigators noted, the success of a hair-epilation laser reinforces primary follicular involvement in HS. Beyond Nd:YAG, laser hair-removal (LHR) platforms have also demonstrated efficacy. A randomized controlled trial of 755-nm alexandrite LHR in mild-to-moderate HS showed improvements on validated clinical measures (e.g., HiSCR), with acceptable safety, again pointing to the clinical relevance of follicular targeting in reducing inflammatory lesion burden and flares.

Parallel evidence from acne, another follicular occlusion disease, motivates us to investigate 1726-nm (AviClear) sebaceous-selective photothermolysis for HS. Preclinical modeling and in-vivo histology demonstrate that 1726 nm + contact cooling can deliver selective thermal injury to sebaceous glands while sparing surrounding tissue, achieving the canonical endpoint of selective photothermolysis. Clinically, 1726-nm laser studies in acne report significant reductions in inflammatory lesion counts after a short series of treatments, durable improvement at longer follow-up, and favorable tolerability across Fitzpatrick I-VI.

Translating this to HS is biologically plausible for Hurley I-II disease, where new nodule formation remains dominated by follicular events rather than extensive sinus tracts. By reducing sebaceous output and follicular activity, 1726-nm treatment may decrease the frequency and intensity of inflammatory nodules/abscesses, complementing stable background medical therapy (e.g., antibiotics, hormones, or biologics targeting TNF-α/IL-17). Importantly, while energy-based surgery (e.g., CO₂ laser deroofing) is effective for chronic tunnels, a non-ablative, follicle-directed device could address earlier lesional biology, potentially lowering flare rates and delaying progression to scarring disease.

Being tested
AviClear Lase Treatment, Sham (No Treatment)
Keywords
hidradenitis suppurative, inversa acne
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AviClear Lase TreatmentDevice

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

  • Sham (No Treatment)Device

    No active laser treatment

Study groups in NCT07155239
Study groupRoleWhat they receive
Control ArmSham comparatorhandpiece contact, no cooling, no energy
Receives: Device: Sham (No Treatment)
Laser TreatmentExperimentalLaser treatment three sessions at Weeks 0, 4, 8; follow-ups at Weeks 12, 16, 24.
Receives: Device: AviClear Lase Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 16 weeks

  2. 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

    Measured: 16 weeks

Secondary outcomes (1)
  1. Change in depression scale

    Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9), a validated nine-item instrument that assesses depression severity over the preceding 16 weeks.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07155239
Sponsor's protocol ID
WMCREILAS082025
Acronym
WMCREI
Status last verified
Sep 2025
First submitted
26 Aug 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: demographic and general information

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