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

January 2022 | Volume 21 | Issue 1 | 43 | Copyright © January 2022


Published online December 13, 2021

Alison Kang MD, Suzanne L. Kilmer MD

Laser and Skin Surgery Center of Northern California, Sacramento, CA

Abstract
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.

J Drugs Dermatol. 2022;21(1):43-48. doi:10.36849/JDD.6492

INTRODUCTION

Skin laxity and facial wrinkles, clinically referred to as rhytids, are common skin conditions in both men and women and are most commonly found in aging skin.1,4 Skin aging is a complex biological process, influenced by combination of intrinsic (genetics, cellular metabolism, hormone and metabolic processes) and extrinsic (chronic light exposure, pollution, ionizing radiation, chemicals, toxins) factors.5 These factors lead together to cumulative structural and physiological alterations and progressive changes in each skin layer as well as changes in skin appearance.6-9 Gradual loss of skin elastosis leads to the phenomenon of skin sagging.10 The aging of one’s skin contributes to one's external appearance, making skin health an important component of facial aesthetics.

The desire to preserve youth is prevalent in modern society, as a youthful appearance is associated with perceived well-being and physical attractiveness.11-13 The appearance of rhytids can lead to negative psychological impact on patients, causing patients to seek cosmetic treatments.14 Traditionally, rhytids have been treated with surgery, such as rhytidectomy, blepharoplasty, and brow lifts. More recently, however, minimally invasive procedures have gained popularity. Consequently, lasers and light therapy for facial rejuvenation were one of the most common five procedures performed in the USA in 2019.15

Conventionally, ablative and non-ablative laser systems have been used to boost skin laxity, but additional technologies have been developed that utilize energy sources to combat aging skin, such as fractional radiofrequency (FRF). This method utilizes electrodes or needles to deliver energy to the tissue to achieve targeted predetermined fractional epidermal and dermal injury. The injury causes damage to the dermal collagen, which initiates a wound healing response including formation of new collagen, elastin and hyaluronic acid resulting in dermal remodeling and skin tightening.16 The tissue located between