University of Miami
Miami, Florida, 33136, United States
Location status: Recruiting
Location contact
Ariel Eber, MD
CONTACT
NCT Number: NCT07340671
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
Location status: Recruiting
Ariel Eber, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Cutera®, AviClear®
Time frame: Baseline periprocedural and through study completion (an average of 30 weeks)
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)
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)
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)
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 and through study completion (an average of 30 weeks)
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: After data collection is completed (an average of 30 weeks from baseline)
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.
Contact information is provided by the study sponsor or research team.
Leigh Nattkemper, PhD
CONTACT
Maria V Muniz
CONTACT
University of Miami
Other
Evaluating the Efficacy of the 1726nm Laser for the Treatment of Facial Papules in Frontal Fibrosing Alopecia (FFA)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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