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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AviClear Group | Experimental | Participants will be in this group for up to 43 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AviClear | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | Baseline, up to 24 weeks (after final treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain as measured by Visual Analogue Scale Pain Rating Scale | Score range from 0 to 10. Higher score indicates more pain. | Baseline, up to 24 weeks (after final treatment) |
| Change in number of lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel E Eber, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Number of lesions
| 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. | 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 | Baseline, up to 24 weeks (after final treatment) |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |