1726-nm Laser for Hidradenitis Suppurativa

(WMCREI Trial)

Overseen By Molynna Nguyen Clinical Research Manager, BS, MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Wynn Medical Center

Must not be taking: Systemic retinoids, Photosensitizing meds

Disqualifiers: Hurley III, Pregnancy, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 1726-nm diode laser can safely reduce painful skin lumps and inflammation in individuals with early-stage hidradenitis suppurativa (HS), a chronic condition affecting areas like the armpits and groin. The study involves using the laser on one side of the body while the other side receives a placebo treatment, comparing results to assess improvement. Individuals with HS who have painful lumps on both sides of areas like the armpits or groin and have not received recent treatments in these areas might be suitable candidates. The aim is to discover a new, non-invasive option for managing early HS symptoms. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial does not require you to stop your current HS medications, as participants will continue their stable HS medications during the study.

What prior data suggests that this laser is safe for treating hidradenitis suppurativa?

Research has shown that the 1726-nm laser is safe and well-tolerated for treating skin conditions like acne, which resemble hidradenitis suppurativa. One study found it effective across different skin types, with safety confirmed for up to six months post-treatment. Another study noted that the laser treatment improved symptoms for at least 26 weeks without major side effects. These findings suggest that the laser might safely reduce painful skin lumps and abscesses in hidradenitis suppurativa, though further research is needed to confirm these results for this specific condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HS?

The 1726-nm laser treatment is unique for hidradenitis suppurativa because it uses a specific wavelength of light energy to target affected areas without the need for systemic medications. Unlike traditional treatments such as antibiotics, anti-inflammatory drugs, or surgical interventions, this laser therapy aims to reduce inflammation and lesion size directly through precise, localized application. Researchers are excited about this treatment because it offers a non-invasive alternative with potentially fewer side effects and quicker recovery times compared to conventional methods.

What evidence suggests that the 1726-nm laser might be an effective treatment for hidradenitis suppurativa?

This trial will compare the 1726-nm laser treatment with a sham comparator for hidradenitis suppurativa (HS). Research has shown that the 1726-nm laser may help treat skin conditions. In one study, the number of people with clear or nearly clear skin increased from 0% to over 40% after using this laser. The laser targets oil glands in hair follicles, reducing inflammation, similar to its effect on acne. Early results suggest it might also reduce painful skin bumps in conditions like HS. These findings offer hope that this laser could become a new way to manage HS symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Huynh Wynn Tran CEO/Founder, MD FACP

Principal Investigator

Wynn Medical Center Research and Education Institute

Molynna Nguyen Clinical Research Manager, BS

Principal Investigator

Wynn Medical Center Research and Education Institute

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate Hidradenitis Suppurativa (HS), having painful lumps in areas like armpits and groin. Participants must have stable HS medication use, bilateral affected areas, and be able to attend multiple treatment sessions.

Inclusion Criteria

Able to read/speak English/Chinese/Spanish/Vietnamese and sign consent

Willing and able to comply with visits, pre/post-care, and standardized photography

Agree to avoid new HS procedures/therapies in study areas through Week 24

Exclusion Criteria

No qualifying nodule(s) in paired bilateral regions in the past 4 weeks

Pregnancy/breastfeeding/plans to conceive during the study

Active infection, still healing wounds (investigator judgment) in target areas

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1726-nm diode laser treatment on one side and a sham procedure on the other side, with three sessions over 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-ups through Week 24

16 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 1726-nm Laser

Trial Overview The study tests a 1726-nm diode laser's ability to reduce inflammatory lesions in HS against a sham procedure. One side of the body gets real treatment; the other gets fake treatment. The main goal is to see if there's a change in lesion counts after treatments.

How Is the Trial Designed?

Group I: Laser Treatment Experimental Treatment 1 Intervention

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

Group II: Control Arm Placebo Group 1 Intervention

handpiece contact, no cooling, no energy

Who Is Running the Clinical Trial?

Wynn Medical Center

Lead Sponsor

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962223010757

Novel 1726 nm laser demonstrates durable therapeutic ... The percentage of subjects clear or almost clear increased from 0% at baseline to 9%, 36.0%, and 41.8% at 4-, 12-, and 26-weeks follow-up. No serious adverse ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06801795

NCT06801795 | Aviclear for Hidradenitis Suppurativa (HS) The objective is to evaluate the safety and efficacy of the Cutera 1726 nm laser system (also referred to as AviClear) for the treatment of HS. Official ...

3. jaad.org jaad.org/article/S0190-9622(25)02900-7/fulltext

Safe and effective acne treatment across skin types with a ... Patients treated with a 1726-nm laser showed significant improvement in moderate-to-severe acne for ≥6 months in a prospective study. Objective.

4. trial.medpath.com trial.medpath.com/clinical-trial/2f6e6bb484f10f1c/nct07155239-aviclear-laser-for-hidradenitis-suppurativa

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa) Clinically, 1726-nm laser studies in acne report significant reductions in inflammatory lesion counts after a short series of treatments, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41201673/

Systematic review of laser and Light-Based procedural ... Objective This systematic review evaluates the efficacy and safety of procedural treatment, including IPL, CO2, and Nd: YAG, in the treatment of ...

6. trialx.com trialx.com/clinical-trials/listings/314278/1726-nm-laser-for-acne-inversa-hidradenitis-suppurativa/

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa) 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 ...

7. patlynk.com patlynk.com/trial/NCT07155239

WMCREI | 1726-nm Laser for Hidradenitis Suppurativa Relief The study aims to see if using the 1726-nm laser can effectively reduce the formation of new inflamed lumps and abscesses by targeting the hair follicles and ...