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1726-nm Laser for Hidradenitis Suppurativa Relief

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Study AimThis study aims to evaluate the safety and initial effectiveness of a 1726-nm laser treatment for providing relief to individuals suffering from hidradenitis suppurativa.
What is being tested

AviClear Lase Treatment

+ Sham (No Treatment)
Device
Who is being recruted

Hidradenitis Suppurativa (HS)

From 18 to 60 Years
+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 1
Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorWynn Medical Center
Study ContactMolynna Nguyen Clinical Research Manager, BS, MA
Last updated: September 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 15, 2025Actual date on which the first participant was enrolled.

This study focuses on using a 1726-nm laser called AviClear for treating a skin condition known as hidradenitis suppurativa (HS). HS is a chronic condition that causes painful lumps and abscesses, especially in areas where skin rubs together. It affects people with Hurley stage I-II HS, where the condition is dominated by issues related to hair follicles rather than more severe symptoms. 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 sebaceous glands, which may help in managing the symptoms better and complement other treatments like antibiotics or hormonal therapy. Participants in this study will receive treatment using the AviClear laser, which is applied directly to the skin. By delivering controlled heat to the sebaceous glands, the laser aims to reduce their activity without harming surrounding tissues. The effectiveness of this treatment will be evaluated based on its ability to lower the frequency and severity of HS symptoms, such as nodules and abscesses. The study is designed as a randomized, split-body trial, meaning participants will receive the laser treatment on one side of their body while the other side receives a sham treatment for comparison. This approach helps in accurately assessing the laser's effectiveness. The trial also focuses on ensuring that the treatment is safe and well-tolerated by participants.

Official Title1726-nm Laser (AviClear) for Hidradenitis Suppurativa (HS): A Randomized Split-Body, Sham-Controlled Pilot Trial 
Principal SponsorWynn Medical Center
Study ContactMolynna Nguyen Clinical Research Manager, BS, MA
Last updated: September 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hidradenitis Suppurativa (HS)
Criteria
8 inclusion criteria required to participate
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

Show More Criteria

11 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Sham
handpiece contact, no cooling, no energy
Group II
Experimental
Laser treatment three sessions at Weeks 0, 4, 8; follow-ups at Weeks 12, 16, 24.
Study Objectives
Primary Objectives

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.

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

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Wynn Medical Center Rheumatology/DermatologyRosemead, United StatesSee the location
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One Study Center