PMID- 31074161 OWN - NLM STAT- MEDLINE DCOM- 20191213 LR - 20191217 IS - 1473-2165 (Electronic) IS - 1473-2130 (Linking) VI - 18 IP - 3 DP - 2019 Jun TI - A multi-center comparative efficacy and safety study of two different hyaluronic acid fillers for treatment of nasolabial folds in a Chinese population. PG - 755-761 LID - 10.1111/jocd.12916 [doi] AB - BACKGROUND: Nonsurgical injectable treatments, including hyaluronic acid (HA) fillers, are increasingly used in Asian patients. AIMS: To demonstrate the efficacy and safety of Restylane Lyft compared to Restylane for the correction of nasolabial folds (NLFs). PATIENTS/METHODS: This was a randomized, evaluator-blinded, split-face, 12-month study conducted in China using Restylane Lyft in the aesthetic correction of moderate to severe NLFs among adult subjects. One NLF was treated with Restylane Lyft, and the opposite NLF with the comparator Restylane. Efficacy outcomes included improvement in the Wrinkle Severity Rating Scale (WSRS) and aesthetic improvement (using the Global Aesthetic Improvement Scale [GAIS] assessed by the subject and blinded evaluator) for each treatment at Months 3, 6 (primary objective based on WSRS), 9, and 12. Safety was evaluated by the incidence of injection site reactions and adverse events (AEs). RESULTS: A total of 100 subjects were randomized to the treatments. Noninferiority for Restylane Lyft was established according to blinded evaluation of WSRS at 6 months after last treatment. Similarly, the WSRS improved throughout the study, and the responder rate (improvement in WSRS of >/=1 grade from Baseline) was sustained after 6 months (64% and 65% for NLFs treated with Restylane and Restylane Lyft, respectively). For GAIS after 6 months, improvement was approximately 80% in both groups. No treatment-related serious AEs were reported. The safety profiles were similar between the two treatments. CONCLUSIONS: Similar to Restylane, Restylane Lyft was effective and well tolerated for treatment of moderate to severe NLFs in this Chinese population. CI - (c) 2019 The Authors. Journal of Cosmetic Dermatology Published by Wiley Periodicals, Inc. FAU - Li, Dong AU - Li D AUID- ORCID: 0000-0003-4955-8008 AD - Peking University Third Hospital, Beijing, China. FAU - Sun, Jiaming AU - Sun J AD - Union Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China. FAU - Wu, Sufan AU - Wu S AD - Zhejiang Provincial People's Hospital, Hangzhou, China. LA - eng GR - Galderma/ PT - Comparative Study PT - Equivalence Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20190510 PL - England TA - J Cosmet Dermatol JT - Journal of cosmetic dermatology JID - 101130964 RN - 0 (Dermal Fillers) RN - 9004-61-9 (Hyaluronic Acid) RN - S270N0TRQY (Restylane) SB - IM MH - Adult MH - China MH - Cosmetic Techniques/*adverse effects MH - Dermal Fillers/*administration & dosage/adverse effects MH - Double-Blind Method MH - Esthetics MH - Female MH - Humans MH - Hyaluronic Acid/administration & dosage/adverse effects/*analogs & derivatives MH - Incidence MH - Injection Site Reaction/*epidemiology/etiology MH - Male MH - Middle Aged MH - Nasolabial Fold MH - *Skin Aging MH - Treatment Outcome OTO - NOTNLM OT - Wrinkle Severity Rating Scale (WSRS) OT - chinese OT - hyaluronic acid OT - nasolabial folds OT - restylane OT - restylane Lyft EDAT- 2019/05/11 06:00 MHDA- 2019/12/18 06:00 CRDT- 2019/05/11 06:00 PHST- 2018/11/16 00:00 [received] PHST- 2019/02/10 00:00 [revised] PHST- 2019/02/12 00:00 [accepted] PHST- 2019/05/11 06:00 [pubmed] PHST- 2019/12/18 06:00 [medline] PHST- 2019/05/11 06:00 [entrez] AID - 10.1111/jocd.12916 [doi] PST - ppublish SO - J Cosmet Dermatol. 2019 Jun;18(3):755-761. doi: 10.1111/jocd.12916. Epub 2019 May 10.