Ji Yeon Hong1, Eun Ja Choi1, Sun Young Choi2, Kapsok Li1, Beom Joon Kim1. 1. Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Republic of Korea. 2. Department of Dermatology, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea.
Abstract
BACKGROUND: Comparative research on the characteristics of filler products is limited, especially in the preclinical analysis of hyaluronic acid (HA) fillers. OBJECTIVE: This study was performed to compare the preclinical characteristics, clinical efficacy, and safety of a new HA filler, IDHF-001, with Restylane SubQ in the treatment of nasolabial folds (NLFs). METHODS:Viscoelasticity and injection force were evaluated. Ninety-one subjects were enrolled in this randomized, patient/evaluator-blind, intraindividual clinical study. Each subject was randomized to receive injections of IDHF-001 or Restylane SubQ in their left or right NLF. At 4, 8, 16, 24, 36, and 48 weeks, all participants were evaluated through Wrinkle Severity Rating Scale (WSRS). RESULTS: The IDHF-001 showed higher viscosity (1,271 Pa·s), lower elastic modulus (G'; 611 Pa), and lower injection force (8.89 N) than Restylane SubQ (464.6 Pa·s; 674.8 Pa; 19.14 N). No significant difference in WSRS was detected between IDHF-001 side and Restylane SubQ side at 24 weeks (mean improvement in WSRS from baseline at Week 24-IDHF-001: 1.85 ± 0.61, Restylane SubQ: 1.88 ± 0.61). The noninferiority was sustained until Week 48. CONCLUSION: The novel HA filler IDHF-001 shows suitable characteristics and tolerability, widening the selection possibilities for clinicians and patients in the treatment of NLFs.
RCT Entities:
BACKGROUND: Comparative research on the characteristics of filler products is limited, especially in the preclinical analysis of hyaluronic acid (HA) fillers. OBJECTIVE: This study was performed to compare the preclinical characteristics, clinical efficacy, and safety of a new HA filler, IDHF-001, with Restylane SubQ in the treatment of nasolabial folds (NLFs). METHODS: Viscoelasticity and injection force were evaluated. Ninety-one subjects were enrolled in this randomized, patient/evaluator-blind, intraindividual clinical study. Each subject was randomized to receive injections of IDHF-001 or Restylane SubQ in their left or right NLF. At 4, 8, 16, 24, 36, and 48 weeks, all participants were evaluated through Wrinkle Severity Rating Scale (WSRS). RESULTS: The IDHF-001 showed higher viscosity (1,271 Pa·s), lower elastic modulus (G'; 611 Pa), and lower injection force (8.89 N) than Restylane SubQ (464.6 Pa·s; 674.8 Pa; 19.14 N). No significant difference in WSRS was detected between IDHF-001 side and Restylane SubQ side at 24 weeks (mean improvement in WSRS from baseline at Week 24-IDHF-001: 1.85 ± 0.61, Restylane SubQ: 1.88 ± 0.61). The noninferiority was sustained until Week 48. CONCLUSION: The novel HA filler IDHF-001 shows suitable characteristics and tolerability, widening the selection possibilities for clinicians and patients in the treatment of NLFs.
Authors: Adele Sparavigna; Beatrice Tenconi; Andrea Maria Giori; Gilberto Bellia; Laura La Penna Journal: Clin Cosmet Investig Dermatol Date: 2019-01-17
Authors: Tomasz Stefura; Artur Kacprzyk; Jakub Droś; Marta Krzysztofik; Oksana Skomarovska; Marta Fijałkowska; Mateusz Koziej Journal: Aesthetic Plast Surg Date: 2021-07-13 Impact factor: 2.708