Evaluation of safety and efficacy of the TriFractional RF technology for treatment of facial wrinkles.

INTRODUCTION Skin resurfacing is an accepted gold standard for the treatment of skin laxity, photodamage, and appearance of visible lines and wrinkles. However, the relatively significant risk and the long downtime associated with whole area resurfacing treatments have led to the introduction of fractional resurfacing lasers and radiofrequency (RF) technologies. This study was performed in order to evaluate the safety and efficacy of the new TriFractional technology using the 3F Applicator (A3F), designed to enable skin resurfacing and treatment of wrinkles using fractional RF energy. METHODS Thirty-two subjects were recruited in two sites and were treated with the A3F for the reduction of facial wrinkles and followed for 3 months after the last treatment. The safety of using the TriFractional system was established by the physicians' assessments and observations of adverse events after each treatment. To evaluate treatment efficacy, subject's pretreatment and posttreatment digital images were assessed and graded by two blinded uninvolved physicians based on Fitzpatrick Wrinkle and Elastosis scale. RESULTS No significant adverse side effects were detected or reported. Evaluation of photographs of study subjects at baseline and 3 months follow-up by the two blinded physicians, revealed improvement (downgrade of at least 1 score according to the Fitzpatrick scale) in 80% and 73% of subjects as graded by the two reviewers. Study subjects reported no pain to moderate pain during treatment with no need of pain relief medication beyond topical anesthesia. The majority of study subjects (83.3%) noted that treatment results met their expectations to different extent levels, and most of study subjects (70%) indicated that they will recommend the A3F treatment to their friends. CONCLUSIONS The results of this study clearly indicate that the TriFractional technology using the 3F applicator provides a safe, tolerable, and effective treatment of facial wrinkles.