Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
The study will evaluate 50 treatment sites in subjects requesting treatment of their facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
Scripps Clinic Carmel Valley
San Diego, California, United States
Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
Time frame: 12 Weeks Post Last Treatment (Around Week 20)
Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
Time frame: 6 Weeks Post Last Treatment (Around Week 14)
Subject Scale - Visual Analog Scale for Pain
Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being pain as bad as it can be. For each subject, the mean VAS score was taken from the 3 treatments.
Time frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.
Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken.
Time frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
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