Safety and Effectiveness of Synchronized Monopolar Radiofrequency and HIFES in Patients Injected With Botulinum Toxin

November 2024 | Volume 23 | Issue 11 | 937 | Copyright © November 2024


Published online October 23, 2024

doi:10.36849/JDD.7938

Suneel Chilukuri MD FAAD FACMS

Refresh Dermatology, Houston, TX

Abstract
Background: Botulinum toxin (BT) has become one of the most frequently sought aesthetic procedures for wrinkle reduction.
Objective: This study investigated the effectiveness and safety of a novel device using radiofrequency (RF) and high-intensity facial muscle stimulation (HIFES) in patients injected with BT.
Methods: Twelve patients were divided into an Active (N=10) and a Control group (N=2), where the Active received four treatments and the Control none. The facial expressions documented by digital photographs (neutral) and videos (frown, smile, surprise expressions) were taken at all visits (baseline, after last Tx, 1 and 3-month follow-ups) and were evaluated using the Global Aesthetic Improvement Scale (GAIS) and 3D automated analysis. The subject's therapy comfort and satisfaction were assessed.
Results: The Active group reported high satisfaction with treatment comfort (6.3±0.2 points on the 7-point Likert scale). 3D analysis showed reduced wrinkle severity (37.4%) and volume increase (+1.5 mL) on the cheeks at 3 months. GAIS evaluation demonstrated the most prominent improvement in smiling facial expression by 2.2±0.1 points. No adverse events were observed.
Conclusion: The study results suggest that the combination of HIFES and synchronized RF is a safe and effective treatment for improving facial appearance and muscle tone in patients injected with BT.

J Drugs Dermatol. 2024;23(11):937-942.  doi:10.36849/JDD.7938

INTRODUCTION

To mitigate the signs of aging, including wrinkles and fine lines resulting from loss of collagen, elastin, and hyaluronic acid, individuals often resort to cosmetic interventions.1-5 Botulinum toxin (BT) has emerged as a popular option for those seeking a rapid and non-invasive approach to achieving a more rejuvenated and refreshed look. It is currently among the most frequently sought-after aesthetic procedures.6 BT-based wrinkle treatment involves injecting small amounts of the toxin into specific muscles of the face, causing temporary weakening or paralysis of the targeted muscles by blocking the pre-synaptic release of acetylcholine, a neurotransmitter that regulates muscle contractions in the injected region.7-11 In order to sustain these effects, patients need to undergo multiple treatments since the effects of BT typically last from three to four months.8 Despite the effectiveness of BT treatment, the risk of developing resistance can arise, and the facial muscles can become weaker due to continuous treatment, eventually leading to facial muscle atrophy.12-17 Facial muscle atrophy, especially in elevator muscles, is not desired and may negatively contribute to the loss of natural support and a sunken appearance, which can be especially problematic in areas such as the cheeks and temples. To enhance the rejuvenating effects of BT treatment and mitigate its potential disadvantages, we investigated the use of a novel non-invasive device that delivers monopolar radiofrequency (RF) and HIFES technology simultaneously. HIFES technology stimulates and tones specific facial elevator muscles (frontalis muscle, zygomaticus major and minor muscles, and risorius muscle) and overlying fascial tissue. Synchronized RF heating induces structural changes in collagen and elastin fibers without exceeding the 43°C threshold needed for fat apoptosis initiation.18 

The combination of RF and HIFES treatment with BT-based injections may become the ideal method to preserve and support the facial elevators’ proper and healthy function while still having the high rejuvenating effect of BT treatment. The safety of RF, when used in conjunction with BT injections, is well-established, as it does not result in any migration or deactivation of the BT.19,20  However, further investigation is required for the RF and HIFES technology combination. The aim of the study was to investigate the safety and effectiveness of the novel technology in patients injected with BT and its effects on overall facial appearance.