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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Participants will receive as many as 4 treatments, each treatment lasts approximately 10 minutes, with intervals of up to 5 weeks apart. The treatments will be conducted in person. Participants will be followed at approximately week 5 post-treatment completion (via phone) at 12 weeks and 24 weeks post treatment completion onsite. This is a 1726 nanometer laser treatment
University of Miami
Miami, Florida, United States
RECRUITINGChange in HiSCR50 as measured by percentage of participants
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50, where HiSCR50 is defined as at least a 50% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
Time frame: Baseline, up to 24 weeks (after final treatment)
Change in pain as measured by Visual Analogue Scale Pain Rating Scale
Score range from 0 to 10. Higher score indicates more pain.
Time frame: Baseline, up to 24 weeks (after final treatment)
Change in number of lesions
Number of lesions
Time frame: Baseline, up to 24 weeks (after final treatment)
Change in IHS 4
The International Hidradenitis Suppurativa 4 (IHS 4) score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
Time frame: Baseline, up to 24 weeks (after final treatment)
Change in number of Patient's stage category as measured by Hurley Stage
The unit of measure for this outcome is the change in number of patient's stage category. The different Hurley Stages are as follows: Patient's stage category I: Single of multiple abscess formation without sinus tracts and cicatrization Patient's stage category II: Recurrent single or multiple abscesses, widely separated, with limited sinus tracts and cicatrization Patient's stage category III: Diffuse or near-diffuse involvement of multiple interconnected tracts and abscesses across an entire area
Time frame: Baseline, up to 24 weeks (after final treatment)
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