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J Dermatolog Treat. 2019 Jun 14:1-6. doi: 10.1080/09546634.2019.1623859. [Epub ahead of print]

The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trial.

Author information

1
a Department of Dermatology , University of Ulsan College of Medicine, Asan Medical Center , Seoul , Republic of Korea.
2
b Department of Dermatology , Chung-Ang University College of Medicine , Seoul , Republic of Korea.

Abstract

Background: Multiple types of fillers have been developed for soft tissue augmentation. Objective: We investigated the efficacy and safety of the novel filler BM-PHA. Methods: In this multicenter, randomized, split-face study, 91 participants received injections of BM-PHA and Restylane Perlane (PER) into the nasolabial folds. Efficacy was determined by the improvements in the Wrinkle Severity Rating Score (WSRS) and Global Esthetic Improvement Scale (GAIS), and safety by adverse events, laboratory tests, and a check of vital signs. Results: WSRS scores assessed by independent evaluators at Week 24, the primary efficacy measure, showed no significant difference between the two treatments. The treatments also showed no significant differences in WSRS scores assessed by the evaluators at Week 8 and WSRS and GAIS scores assessed by the treating investigators and participants at Weeks 8 and 24. The proportion of nasolabial folds whose WSRS scores improved by at least one grade at Week 24 was similar between the treatments. Only minor local side effects were reported without sequelae. Conclusion: BM-PHA was not inferior to PER in the treatment of moderate to severe nasolabial folds and may be an appropriate alternative product for their improvement. Further studies are needed to confirm the long-term safety of BM-PHA.

KEYWORDS:

BM-PHA; hyaluronic acid; nasolabial fold

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