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.
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
Huynh W Tran MD CEO/Founder, MD FACP contact
United States1 site, 1 recruiting
- Recruiting
Wynn Medical Center Rheumatology/Dermatology
Rosemead, California, 91770
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.
- Conditions
- Hidradenitis Suppurativa (HS)
- 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 group | Role | What they receive |
|---|---|---|
| Control Arm | Sham comparator | handpiece contact, no cooling, no energy Receives: Device: Sham (No Treatment) |
| Laser Treatment | Experimental | Laser 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.
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
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)
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.
- First posted4 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wynn Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huynh Wynn Tran MD FACP, Wynn Medical Center
- Investigators
- Huynh Wynn Tran CEO/Founder, MD FACP, Principal investigator, Wynn Medical Center Research and Education InstituteMolynna Nguyen Clinical Research Manager, BS, Study director, Wynn Medical Center Research and Education Institute
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