The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trial
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)...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2021-01-01
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| Series: | Journal of Dermatological Treatment |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/09546634.2019.1623859 |
| _version_ | 1797683674328596480 |
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| author | Seung Hwan Paik Myoung Eun Choi Woo Jin Lee Sung Eun Chang Mi Woo Lee Jee Ho Choi Beom Joon Kim Chong Hyun Won |
| author_facet | Seung Hwan Paik Myoung Eun Choi Woo Jin Lee Sung Eun Chang Mi Woo Lee Jee Ho Choi Beom Joon Kim Chong Hyun Won |
| author_sort | Seung Hwan Paik |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T00:18:35Z |
| format | Article |
| id | doaj.art-e738d446a09847d5b27eafed05c58d76 |
| institution | Directory Open Access Journal |
| issn | 0954-6634 1471-1753 |
| language | English |
| last_indexed | 2024-03-12T00:18:35Z |
| publishDate | 2021-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj.art-e738d446a09847d5b27eafed05c58d762023-09-15T14:23:02ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532021-01-013219510010.1080/09546634.2019.16238591623859The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trialSeung Hwan Paik0Myoung Eun Choi1Woo Jin Lee2Sung Eun Chang3Mi Woo Lee4Jee Ho Choi5Beom Joon Kim6Chong Hyun Won7University of Ulsan College of Medicine, Asan Medical CenterUniversity of Ulsan College of Medicine, Asan Medical CenterUniversity of Ulsan College of Medicine, Asan Medical CenterUniversity of Ulsan College of Medicine, Asan Medical CenterUniversity of Ulsan College of Medicine, Asan Medical CenterUniversity of Ulsan College of Medicine, Asan Medical CenterChung-Ang University College of MedicineUniversity of Ulsan College of Medicine, Asan Medical CenterBackground: 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.http://dx.doi.org/10.1080/09546634.2019.1623859bm-phahyaluronic acidnasolabial fold |
| spellingShingle | Seung Hwan Paik Myoung Eun Choi Woo Jin Lee Sung Eun Chang Mi Woo Lee Jee Ho Choi Beom Joon Kim Chong Hyun Won The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trial Journal of Dermatological Treatment bm-pha hyaluronic acid nasolabial fold |
| title | The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trial |
| title_full | The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trial |
| title_fullStr | The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trial |
| title_full_unstemmed | The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trial |
| title_short | The efficacy and safety of BM-PHA for the correction of nasolabial folds: a multicenter, randomized, double-blind, split-face clinical trial |
| title_sort | efficacy and safety of bm pha for the correction of nasolabial folds a multicenter randomized double blind split face clinical trial |
| topic | bm-pha hyaluronic acid nasolabial fold |
| url | http://dx.doi.org/10.1080/09546634.2019.1623859 |
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