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
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