Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects

Abstract

Xia Dai,1 Li Li,2 Ward Peterson,3,4 Renate R Baumgartner,3 Jinmei Huang,5 Alexandra Baer-Zwick,6 Sonja Hoeller,3 Zrinka Ivezic-Schoenfeld,3 Martin Prinz3 1Department of Plastic and Reconstructive Surgery, The First Hospital Affiliated to Army Medical University, Chongqing, China; 2Department of Dermatology, West China Hospital, Sichuan University, Sichuan, China; 3Clinical Development, CROMA-PHARMA GmbH, Leobendorf, Austria; 4Ward Peterson Consulting, Limited Liability Company, Morrisville, NC 27560, USA; 5Qualtech Consulting Corporation, Taipei, Taiwan; 6Regulatory Affairs, CROMA-PHARMA GmbH, Leobendorf, Austria Background: Modified sodium hyaluronate gel for injection, Princess® VOLUME (PV), has been on the European market since 2009 to correct deeper wrinkles and folds, increasing or restoring volume of the face, and remodeling facial contours.  Objective: To evaluate the safety and effectiveness of PV in correction of moderate-to-severe nasolabial folds (NLF) in Chinese subjects.  Methods: In this prospective, split-face, randomized, evaluator and subject-blinded, multicenter, noninferiority trial, 120 subjects were randomized to bilateral NLF treatment with PV administered in one NLF and Restylane® (RL) administered in the other NLF. NLFs were evaluated using the validated 5-point Wrinkle Severity Rating Scale with scores ranging from 1= none (no visible NLF) to 5= very severe (extremely deep and long NLF). Response was defined as ≥1 point improvement at Week 24 assessed by the blinded independent review committee (IRC) and the reduction of NLF severity, assessed by subjects and IRC based on the Global Aesthetic Improvement Scale.  Results: Among the 115 subjects who completed the study, median initial and touch-up volumes (mL) were 1.00 for both groups with a maximum dosage per NLF of 2.00 and a minimum of 0.30 for PV and 0.60 for RL. At week 24, the Wrinkle Severity Rating Scale improvement rate, as assessed by the IRC, reached 68.70% for PV and 52.17% for RL. The results indicate that PV is noninferior to RL (p<0.001). Most frequently reported adverse events for both devices were injection site swelling and procedural pain. The severity of the majority of the adverse events was mild.  Conclusion: This study confirms that PV is a safe and effective treatment for the correction of moderate-to-severe NLFs in Chinese subjects. Keywords: nasolabial folds, Princess®, Princess® VOLUME, effectiveness, safety, treatment satisfactio