title: Clinical comparison between two hyaluronic acid-derived fillers in the treatment of nasolabial folds in Chinese subjects: BioHyalux versus Restylane.
abstract: Hyaluronic acid fillers are used to improve the appearance of nasolabial folds (NLF). This study aimed to compare the efficacy, safety, and durability of a new hyaluronic acid gel (BioHyalux) versus Restylane for the correction of NLF. This was a multicenter, double-blinded, randomized, controlled, non-inferiority clinical trial involving 88 subjects with moderate to severe NLF. Subjects were randomized to BioHyalux and Restylane on either sides of the NLF. NLF was assessed before and right after injection, and at 1 week, 1, 3, and 6 months. Patients were followed up for 13-15 months to evaluate the durability and long-term safety. A clinically meaningful response was predefined as at least one-point improvement on the Wrinkle Severity Rating Scale, which is a five-point scale. At 6 months, the response rate of BioHyalux was not inferior to that of Restylane (P < 0.05). At the 13-15 months follow-up, the response rate by investigators was 58.0 % on the BioHyalux side versus 63.8 % on the Restylane side. The response rate by subjects showed similar results, which was 56.5 % on the BioHyalux side versus 60.9 % on the Restylane side at 13-15 months. The subjects' Global Aesthetic Improvement Scale (GAIS) showed that most subjects felt improvements on both sides of NLF (P > 0.05) at all time points. At 6 months, 100 % reported improvements on both side; at 13-15 months, 60 % of subjects reported improvements with BioHyalux versus 64 % with Restylane. Adverse events were transient and predominantly mild or moderate in severity including injection site swelling, pain, itching, bruising, and tenderness. BioHyalux had reliable safety and tolerance, and could be an effective injectable filler for correcting NLF.
authors.affiliation: Department of Dermatology, Peking University First Hospital, Beijing, 100034, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Department of Dermatology, Peking University First Hospital, Beijing, 100034, China.
authors.forename: Nan
authors.initials: N
authors.lastname: Sun
authors.affiliation: Department of Dermatology, Peking University First Hospital, Beijing, 100034, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Xu
authors.affiliation: Department of Dermatology, Peking University First Hospital, Beijing, 100034, China.
authors.forename: Huixian
authors.initials: H
authors.lastname: Liu
authors.affiliation: Department of Dermatology, Peking University First Hospital, Beijing, 100034, China.
authors.forename: Shaomin
authors.initials: S
authors.lastname: Zhong
authors.affiliation: Department of Plastic Surgery, Peking University Third Hospital, Beijing, 100191, China.
authors.forename: Liyang
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Plastic Surgery, Peking University Third Hospital, Beijing, 100191, China. lidsci@163.com.
authors.forename: Dong
authors.initials: D
authors.lastname: Li
mesh_terms: D000328:Adult; D044466:Asian People; D003357:Cosmetic Techniques; D000067548:Dermal Fillers / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007279:Injections, Subcutaneous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D060052:Nasolabial Fold; D015595:Skin Aging; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000067548:Dermal Fillers; D006820:Hyaluronic Acid; C445361:Restylane
keywords: BioHyalux; Global Aesthetic Improvement Scale; Hyaluronic acid fillers; Restylane