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| Name | Class |
|---|---|
| Cutera Inc. | INDUSTRY |
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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 facial papules in frontal fibrosing alopecia (FFA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1726 nm Laser Treatment Group | Experimental | Participants will be in this group for up to approximately 30 weeks and complete up to 5 visits |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutera® 1726 nm laser system | Device | Participants will receive 3 laser treatments at 4 (±1) week intervals and will be followed at approximately at 12 (± 2) weeks post treatment completion onsite. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound | Lesion size will be assessed using dermatoscope and ultrasound imaging. Measurements will be recorded in millimeters (mm) and compared to baseline values to evaluate treatment response. | Baseline periprocedural and through study completion (an average of 30 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lesion count measured by physical examination | Lesions will be counted manually during physical examination at each time point. Counts will be compared to baseline to assess treatment response | Baseline periprocedural and through study completion (an average of 30 weeks) |
| Change in lesion depth measured by optical coherence tomography (OCT) and/or ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria V Muniz | Contact | 305-689-2646 | mmuniz@med.miami.edu | |
| Leigh Nattkemper, PhD | Contact | 305-588-9734 | lxn202@med.miami.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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Using optical coherence tomography (OCT) and/or ultrasound to measure subsurface changes, including lesion depth and size. Measurements will be compared to baseline to evaluate treatment response. |
| Baseline, periprocedural, and through study completion (an average of 30 weeks) |
| Change in appearance of facial papules assessed by standardized global photography | Facial papule appearance will be documented using standardized global photographs at each time point. Images will be evaluated for visual changes compared to baseline. | Baseline, periprocedural and through study completion (an average of 30 weeks) |
| Change in Physician Global Assessment (PGA) score (9-point ordinal scale) | A board-certified physician will evaluate overall lesion severity using a standardized 9-point ordinal scale. Scores range from 0-8, with higher scores indicate greater severity. Scores at follow-up will be compared to baseline to assess treatment response. | Baseline and through study completion (an average of 30 weeks) |
| Blinded dermatologist evaluation | Before and after photos will be provided to three blinded dermatologists. Dermatologists will be asked to identify the correct before and after photos. Correct identification greater than or equal to 80% percent of the time is considered statistically significant. | After data collection is completed (an average of 30 weeks from baseline) |