Safety and Effectiveness of Hyaluronic Acid Fillers With Lidocaine for Full-Face Treatment in Asian Patients

September 2020 | Volume 19 | Issue 9 | Original Article | 836 | Copyright © September 2020


Published online August 21, 2020

She-Hung Huang MD PhDa,b, Tsen-Fang Tsai MDc

aDivision of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan bDepartment of Surgery, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan cDepartment of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan *Previously presented at the IMCAS World Congress, Paris, France, 2019, and at the Aesthetic and Anti-aging Medicine World Congress (AMWC), Monte Carlo, Monaco, 2019 and accepted for poster presentation 2020.

Abstract
Background: There is a need for further evaluation of hyaluronic acid fillers for aesthetic use in Asia, where treatment goals may differ from western countries.

Objective:
To evaluate 24-month safety and effectiveness of two hyaluronic acid fillers with lidocaine when used for full-face aesthetic treatment in Asian patients.

Methods:
This was a 24-month, evaluator-blinded, non-comparative, multi-center study. Female subjects were injected with 3-5 mL Restylane® Lidocaine and/or Restylane Lyft Lidocaine, manufactured using the NASHA™ technology, in 2–4 pre-defined areas; upper cheeks, nasolabial folds, temples, nose, and chin. A second treatment was performed after 12 months. Assessments included aesthetic improvement, subject satisfaction, assessment scales for upper cheeks and nasolabial folds, and safety (adverse events and subject diaries).

Results:
One hundred subjects were included; total mean volumes were 4.7 mL and 3.1 mL at first and second treatment, respectively. At least 82% of subjects were rated as aesthetically improved over 24 months by subjects themselves and by investigators. Most subjects (73-90%) were satisfied with the treatment throughout the study. Upper cheek improvement 12 months after treatment was significantly higher after second treatment (≥69% of subjects) than after first treatment (≥38%), P<0.0001, Fisher’s exact test. A total of 29 treatment related adverse events were reported by 16% of subjects, all were mild (79%) or moderate (21%) in intensity. Most commonly reported were pain and bruising. Tenderness was the most common diary record in all treatment areas.

Conclusion:
Full-face treatments with the study products resulted in long-term aesthetic improvement, perceived by both subjects and investigators. Subject satisfaction was high and maintained over 24 months with one re-treatment. Repeated treatment of several facial indications showed a satisfactory safety profile.

J Drugs Dermatol
. 2020;19(9):836-842. doi:10.36849/JDD.2020.5374

INTRODUCTION

Effectiveness and safety of Restylane® Lidocaine (HAR; Galderma, Uppsala, Sweden) and Restylane Lyft Lidocaine (HARL), manufactured using the NASHA™ technology, have been evaluated in clinical studies mostly performed in North America and Europe.1-7 Market research has indicated different treatment needs from clinical practice in Asia (data on file), making it important to collect data on aesthetic treatments in Asian populations. Also, it is of interest to collect additional data on repeated full-face treatments and long-term follow-up. With these factors in mind, the objective of this study was to provide documentation of long-term safety and effectiveness of HAR and HARL when used for repeated full-face treatment in Asian patients. The study products are approved for use in Taiwan, where the study was conducted.

METHODS

Study Design
This was a 24-month, evaluator-blinded, non-comparative, multi-center study (ClinicalTrial.gov ID: NCT02565784). The study was conducted at two hospitals in Taiwan, subjects were recruited from the clinics’ patient records and through advertisement. The study protocol was approved by independent ethics committees and conformed to the Declaration of Helsinki.

Eligibility
Eligible subjects were females with Han Chinese facial appearance, aged 25 to 50 years, with the intention to undergo facial filler treatment for either contouring or to compensate for volume loss. Subjects would in the opinion of the investigator, require treatment in 2–4 of pre-defined areas; upper cheeks, nasolabial folds, temples, nose and chin, with 3–5 mL study product to achieve a clinically meaningful improvement in facial