An interventional study of Cutera® 1726 nm laser system in Frontal Fibrosing Alopecia, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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).
University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be in this group for up to approximately 30 weeks and complete up to 5 visits
Device: Cutera® 1726 nm laser system
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.
Also known as: Cutera®, AviClear®
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 periprocedural and through study completion (an average of 30 weeks)
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 periprocedural and through study completion (an average of 30 weeks)
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, 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.
Time frame: 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.
Time frame: 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.
Time frame: After data collection is completed (an average of 30 weeks from baseline)
Plan to share: No
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