WMCREI1726-nm Laser for Hidradenitis Suppurativa Relief
This study aims to evaluate the safety and initial effectiveness of a 1726-nm laser treatment for providing relief to individuals suffering from hidradenitis suppurativa.
AviClear Lase Treatment
+ Sham (No Treatment)
Bacterial Infections and Mycoses+8
+ Bacterial Infections
+ Infections
Treatment Study
Summary
Study start date: September 15, 2025
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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. * 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
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