A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds
Background We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds. Methods In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identi...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Thieme Medical Publishers, Inc.
2015-11-01
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| Series: | Archives of Plastic Surgery |
| Subjects: | |
| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.5999/aps.2015.42.6.721 |
| _version_ | 1817995738165018624 |
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| author | Changsik Pak Jihoon Park Jinmyung Hong Jaehoon Jeong Saik Bang Chan Yeong Heo |
| author_facet | Changsik Pak Jihoon Park Jinmyung Hong Jaehoon Jeong Saik Bang Chan Yeong Heo |
| author_sort | Changsik Pak |
| collection | DOAJ |
| description | Background We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds.
Methods In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests.
Results Neuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane.
Conclusions In conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings. |
| first_indexed | 2024-04-14T02:11:34Z |
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| id | doaj.art-715c0c18c37649c0ac148d95a2d6d305 |
| institution | Directory Open Access Journal |
| issn | 2234-6163 2234-6171 |
| language | English |
| last_indexed | 2024-04-14T02:11:34Z |
| publishDate | 2015-11-01 |
| publisher | Thieme Medical Publishers, Inc. |
| record_format | Article |
| series | Archives of Plastic Surgery |
| spelling | doaj.art-715c0c18c37649c0ac148d95a2d6d3052022-12-22T02:18:25ZengThieme Medical Publishers, Inc.Archives of Plastic Surgery2234-61632234-61712015-11-01420672172810.5999/aps.2015.42.6.721598A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial FoldsChangsik Pak0Jihoon Park1Jinmyung Hong2Jaehoon Jeong3Saik Bang4Chan Yeong Heo5Department of Plastic and Reconstructive Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, KoreaDepartment of Plastic and Reconstructive Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, KoreaDepartment of Plastic and Reconstructive Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, KoreaDepartment of Plastic and Reconstructive Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, KoreaDepartment of Plastic and Reconstructive Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, KoreaDepartment of Plastic and Reconstructive Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, KoreaBackground We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds. Methods In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests. Results Neuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane. Conclusions In conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings.http://www.thieme-connect.de/DOI/DOI?10.5999/aps.2015.42.6.721hyaluronic acidnasolabial fold |
| spellingShingle | Changsik Pak Jihoon Park Jinmyung Hong Jaehoon Jeong Saik Bang Chan Yeong Heo A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds Archives of Plastic Surgery hyaluronic acid nasolabial fold |
| title | A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds |
| title_full | A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds |
| title_fullStr | A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds |
| title_full_unstemmed | A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds |
| title_short | A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds |
| title_sort | phase iii randomized multi center double masked matched pairs active controlled trial to compare the efficacy and safety between neuramis deep and restylane in the correction of nasolabial folds |
| topic | hyaluronic acid nasolabial fold |
| url | http://www.thieme-connect.de/DOI/DOI?10.5999/aps.2015.42.6.721 |
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