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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
University of Miami
Miami, Florida, United States
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.
Time frame: Baseline (Pretreatment), immediately after each treatment session, and at 12 week follow up
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
Time frame: Baseline (Pretreatment) immediately after each treatment, and at 12 week follow up
Change in lesion depth measured by optical coherence tomography (OCT) and/or ultrasound
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.
Time frame: Baseline (Pretreatment) immediately after each treatment, and at 12 week follow up
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.
Time frame: Baseline (Pretreatment), immediately after each treatment, and at 12 week follow up
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.
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Time frame: Baseline (Pretreatment) and 12 week follow up
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.
Time frame: Up to 30 weeks
Patient's self-assessment (PSA) scale
The Patient Self-Assessment (PSA) is a standardized patient-reported outcome measure of subjective improvement. Patients will rate their improvement using a 5-point Likert scale (1 = no improvement, 5 = significant improvement).
Time frame: At baseline and through the completion of the study, approximate time of 30 weeks