This study will evaluate the clinical efficacy, safety and the performance of the fractional radiofrequency delivered by the BTL-585-4 applicator of the BTL-585F system for non-invasive treatment of acne scars and facial wrinkles. The study is a prospective multicenter open label two-arm study. The subjects will be enrolled and assigned into two study groups, according to their indication; group A (acne scars) and B (facial wrinkles), each study group will receive treatment of different conditions. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.
This study will evaluate the clinical efficacy, safety and the performance of the fractional radiofrequency delivered by the BTL-585-4 applicator of the BTL-585F system for non-invasive treatment of acne scars and facial wrinkles. The study is a prospective multicenter open label two-arm study. The subjects will be enrolled and assigned into two study groups, according to their indication; group A (acne scars) and B (facial wrinkles), each study group will receive treatment of different conditions. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits. At the baseline visit, health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed. In addition photographs of the treated area will be taken. The treatment administration phase in both study groups will consist of three (3) treatment visits, delivered 2-5 weeks apart. Subjects of both groups will receive treatment with the insulated or non-insulated microneedle tip (BTL-585-4-5 or BTL-585-4-6), depending on patients' skin sensitivity, followed by the application of superficial tip 32 (BTL-585-4-7) or 64 (BTL-585-4-8), depending on the size of the treatment site. Treatment settings will be adjusted individually according to the severity of the subjects' condition.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
BTL-585F device with BTL-585-4 applicator
Precision Skin Institute
Davie, Florida, United States
Yael Halaas, M.D., FACS
New York, New York, United States
Change in wrinkle severity
Evaluation of wrinkle severity based on photographs before and after the study procedure.
Time frame: 5 months
Change in acne scars
Evaluation of improvement in acne scars based on photographs before and after the study procedure.
Time frame: 5 months
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Evaluation of the safety of the BTL-585F device with BTL-585-4 applicator for non-invasive reduction of wrinkles and treatment of acne scars by monitoring of adverse events.
Time frame: 5 months
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