BACKGROUND: Three new hyaluronic acid (HA)-based fillers made of long chains crosslinked with reduced amounts of 1,4-butanediol diglycidyl ether (BDDE) were developed for the treatment of dynamic facial areas. Their resilience and increased stretching ability were optimized to ease injectors' practice and provide patients with most natural aesthetic results. OBJECTIVE: This study aimed at evaluating the efficacy, durability, and safety of these resilient HA fillers versus commercially available comparator gels. METHODS: A prospective, monocentric, split-face, double-blinded, randomized, controlled trial was performed on 90 subjects presenting moderate to severe bilateral nasolabial folds (NLFs). Efficacy parameters were assessed over 18 months, including improvement on the Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale, as well as quantitative imaging and analysis of NLF correction. Physicians' and subjects' satisfaction, together with safety, were assessed throughout the study. RESULTS: The new HA fillers offered efficacy and safety profiles at least equivalent to comparators. These dynamic facial fillers elicited higher satisfaction immediately after injection but also on the long run, according to both investigators and subjects. CONCLUSION: This pilot trial demonstrated the numerous benefits of 3 new resilient HA fillers with decreased BDDE crosslinking in the treatment of dynamic wrinkles.
RCT Entities:
BACKGROUND: Three new hyaluronic acid (HA)-based fillers made of long chains crosslinked with reduced amounts of 1,4-butanediol diglycidyl ether (BDDE) were developed for the treatment of dynamic facial areas. Their resilience and increased stretching ability were optimized to ease injectors' practice and provide patients with most natural aesthetic results. OBJECTIVE: This study aimed at evaluating the efficacy, durability, and safety of these resilient HA fillers versus commercially available comparator gels. METHODS: A prospective, monocentric, split-face, double-blinded, randomized, controlled trial was performed on 90 subjects presenting moderate to severe bilateral nasolabial folds (NLFs). Efficacy parameters were assessed over 18 months, including improvement on the Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale, as well as quantitative imaging and analysis of NLF correction. Physicians' and subjects' satisfaction, together with safety, were assessed throughout the study. RESULTS: The new HA fillers offered efficacy and safety profiles at least equivalent to comparators. These dynamic facial fillers elicited higher satisfaction immediately after injection but also on the long run, according to both investigators and subjects. CONCLUSION: This pilot trial demonstrated the numerous benefits of 3 new resilient HA fillers with decreased BDDE crosslinking in the treatment of dynamic wrinkles.