Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Wrinkles: A Prospective Study

Background: Fractional radiofrequency (FRF) technology has been shown in clinical studies to improve skin laxity, and to treat various skin conditions related to aging and alternate collagen structures such as rhytids. The objective of this clinical study was to evaluate the safety and performance of FRF (up to 124 mJ per pin) for the treatment of facial rhytids, emphasizing the upper lip and perioral areas. Methods: Enrolled subjects received a series of 3 FRF treatments to the full face, 3 to 5 weeks apart. Immediately after treatment, the subjects were given a scale to assess pain and tolerability of the treatment. Subject satisfaction questionnaires were completed at follow-up visits at 6 and 12 weeks post final treatment. Before and after photographs were graded for change by three blinded evaluators using the Fitzpatrick Wrinkle and Elastosis Scale (FWES) and the Global Aesthetic Improvement Scale (GAIS). Results: Image sets of 10 enrolled subjects (average age 62.7 years) were assessed by blinded evaluators. The overall face FWES score improved from 5.97 (SE 0.20) at baseline to 5.78 (SE 0.22) at 12-week follow-up. The GAIS improved by 0.4 points and was significant compared to baseline (P= 0.0004). Subject satisfaction was high with subjects giving an average satisfaction score of 3.2 ("satisfied") out of 4. Pain was rated "mild to moderate" with an average of 3.9 on a 11 -point Wong Baker FACES Scale. Ninety percent (90%) of subjects reported either a mild, moderate, or significant improvement to their treatment area. Eighty percent (80%) of subjects reported that they would recommend the treatment to a friend. There were no reports of adverse events or unanticipated side effects during the duration of the study. Conclusion: A statistically significant reduction in rhytids of the upper lip and the perioral area, was found, as evaluated by independent blinded evaluators. There were no adverse events. Treatment pain was low and tolerable, and subjects had high levels of satisfaction with the results at last follow-up.