Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring. The study will evaluate the progress of 20 subjects requesting treatment of acne scarring. 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
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The Venus Viva™ MD fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids, and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Sadick Research Group
New York, New York, United States
Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
Time frame: 12 Weeks Post-Final Treatment
Treatment Pain
Subject's assessment of discomfort and pain assessed immediately after treatments as measured by a 10 cm visual analog scale (VAS). The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be).
Time frame: Average of all treatments
Subject Scale - 5 Point Scale for Treatment Tolerability
Subject's assessment of treatment tolerability as measured by a 5 point scale. Participants were asked about their treatment tolerability level immediately post-treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.
Time frame: Average of all treatments
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