Post Hoc Non-inferiority Analysis of the Efficacy of Poly-L-Lactic Acid Filler (Gana V versus Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Randomized, Split-Face Controlled Trial

doi:10.1007/s00266-024-04629-3

. 2024 Dec 28.

doi: 10.1007/s00266-024-04629-3. Online ahead of print.

Post Hoc Non-inferiority Analysis of the Efficacy of Poly-L-Lactic Acid Filler (Gana V versus Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Randomized, Split-Face Controlled Trial

Hyeon Jin Kim^#^{1

2}, Jiseung Kang^#^{3

4}, Dong Keon Yon^{5

6

7}

Affiliations

¹ Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea.
² Department of Regulatory Science, Kyung Hee University, Seoul, South Korea.
³ Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.
⁴ Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA.
⁵ Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea. yonkkang@gmail.com.
⁶ Department of Regulatory Science, Kyung Hee University, Seoul, South Korea. yonkkang@gmail.com.
⁷ Department of Pediatrics, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, South Korea. yonkkang@gmail.com.

^# Contributed equally.

PMID: 39733049
DOI: 10.1007/s00266-024-04629-3

Post Hoc Non-inferiority Analysis of the Efficacy of Poly-L-Lactic Acid Filler (Gana V versus Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Randomized, Split-Face Controlled Trial

Hyeon Jin Kim et al. Aesthetic Plast Surg. 2024.

. 2024 Dec 28.

doi: 10.1007/s00266-024-04629-3. Online ahead of print.

Authors

Hyeon Jin Kim^#^{1

2}, Jiseung Kang^#^{3

4}, Dong Keon Yon^{5

6

7}

Affiliations

¹ Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea.
² Department of Regulatory Science, Kyung Hee University, Seoul, South Korea.
³ Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.
⁴ Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA.
⁵ Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea. yonkkang@gmail.com.
⁶ Department of Regulatory Science, Kyung Hee University, Seoul, South Korea. yonkkang@gmail.com.
⁷ Department of Pediatrics, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, South Korea. yonkkang@gmail.com.

^# Contributed equally.

PMID: 39733049
DOI: 10.1007/s00266-024-04629-3

No abstract available

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Conflict of interest statement

Declarations. Conflict of interest: Prof. Dong Keon Yon reports being funded by the GCS to conduct clinical trials in collaboration with Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). No other potential conflict of interest relevant to this article was reported. Ethical Approval: This study was approved by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM; IRB number, 2021-A02451-40) and was registered in the ClinicalTrials (identifier number, NCT05215054). This study adhered to the tenets of the Declaration of Helsinki. Informed Consent: Informed consent was obtained from all patients.

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References

1. Han WY, Kim HJ, Kwon R, Kang SM, Yon DK (2023) Safety and efficacy of poly-L-lactic acid filler (Gana V vs. Sculptra) injection for correction of the nasolabial fold: a double-blind, non-inferiority, randomized, split-face controlled trial. Aesthet Plast Surg 47:1796–1805 - DOI
1. Avelar L, Ong A, Ong D, Wai ACS, Wai AYT, Sungkyu J, Seok LH, Tam E, Leng SE, Huang J, Chao Y, Brasater D, Prygova I (2023) Consensus recommendations on the use of injectable poly-l-lactic acid in Asian patients. J Cosmet Dermatol 22:3223–3231 - DOI - PubMed
1. Shuai C, Wang Z, Zhang H, Jia J, Huang L, Wang D, Chen S, Feng P (2022) Biosoluble ceramic fiber reinforced poly(L-lactic acid) bone scaffold: degradation and bioactivity. npj Mater Degrad 6:87 - DOI
1. Fabi S, Hamilton T, LaTowsky B, Kazin R, Marcus K, Mayoral F, Joseph J, Hooper D, Shridharani S, Hicks J, Brasater D, Weinberg F, Prygova I (2024) Effectiveness and safety of sculptra poly-L-lactic acid injectable implant in the correction of cheek wrinkles. J Drugs Dermatol 23:1297–1305 - DOI - PubMed
1. Wanitphakdeedecha R, Ng JNC, Phumariyapong P, Nokdhes YN, Patthamalai P, Tantrapornpong P, Suphatsathienkul P, Apinuntham C, Yan C, Nanchaipruek Y, Thongjaroensirikul P, Maneeprasopchoke P, Techapichetvanich T, Eimpunth S, Manuskiatti W, Thanachaipiwat S, Panich U (2023) A pilot study comparing the efficacy of autologous cultured fibroblast injections with hyaluronic acid fillers for treating nasolabial folds. Sci Rep 13:6616 - DOI - PubMed - PMC

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[1] Han WY, Kim HJ, Kwon R, Kang SM, Yon DK (2023) Safety and efficacy of poly-L-lactic acid filler (Gana V vs. Sculptra) injection for correction of the nasolabial fold: a double-blind, non-inferiority, randomized, split-face controlled trial. Aesthet Plast Surg 47:1796–1805 - DOI

[2] Han WY, Kim HJ, Kwon R, Kang SM, Yon DK (2023) Safety and efficacy of poly-L-lactic acid filler (Gana V vs. Sculptra) injection for correction of the nasolabial fold: a double-blind, non-inferiority, randomized, split-face controlled trial. Aesthet Plast Surg 47:1796–1805 - DOI

[3] Avelar L, Ong A, Ong D, Wai ACS, Wai AYT, Sungkyu J, Seok LH, Tam E, Leng SE, Huang J, Chao Y, Brasater D, Prygova I (2023) Consensus recommendations on the use of injectable poly-l-lactic acid in Asian patients. J Cosmet Dermatol 22:3223–3231 - DOI - PubMed

[4] Avelar L, Ong A, Ong D, Wai ACS, Wai AYT, Sungkyu J, Seok LH, Tam E, Leng SE, Huang J, Chao Y, Brasater D, Prygova I (2023) Consensus recommendations on the use of injectable poly-l-lactic acid in Asian patients. J Cosmet Dermatol 22:3223–3231 - DOI - PubMed

[5] Shuai C, Wang Z, Zhang H, Jia J, Huang L, Wang D, Chen S, Feng P (2022) Biosoluble ceramic fiber reinforced poly(L-lactic acid) bone scaffold: degradation and bioactivity. npj Mater Degrad 6:87 - DOI

[6] Shuai C, Wang Z, Zhang H, Jia J, Huang L, Wang D, Chen S, Feng P (2022) Biosoluble ceramic fiber reinforced poly(L-lactic acid) bone scaffold: degradation and bioactivity. npj Mater Degrad 6:87 - DOI

[7] Fabi S, Hamilton T, LaTowsky B, Kazin R, Marcus K, Mayoral F, Joseph J, Hooper D, Shridharani S, Hicks J, Brasater D, Weinberg F, Prygova I (2024) Effectiveness and safety of sculptra poly-L-lactic acid injectable implant in the correction of cheek wrinkles. J Drugs Dermatol 23:1297–1305 - DOI - PubMed

[8] Fabi S, Hamilton T, LaTowsky B, Kazin R, Marcus K, Mayoral F, Joseph J, Hooper D, Shridharani S, Hicks J, Brasater D, Weinberg F, Prygova I (2024) Effectiveness and safety of sculptra poly-L-lactic acid injectable implant in the correction of cheek wrinkles. J Drugs Dermatol 23:1297–1305 - DOI - PubMed

[9] Wanitphakdeedecha R, Ng JNC, Phumariyapong P, Nokdhes YN, Patthamalai P, Tantrapornpong P, Suphatsathienkul P, Apinuntham C, Yan C, Nanchaipruek Y, Thongjaroensirikul P, Maneeprasopchoke P, Techapichetvanich T, Eimpunth S, Manuskiatti W, Thanachaipiwat S, Panich U (2023) A pilot study comparing the efficacy of autologous cultured fibroblast injections with hyaluronic acid fillers for treating nasolabial folds. Sci Rep 13:6616 - DOI - PubMed - PMC

[10] Wanitphakdeedecha R, Ng JNC, Phumariyapong P, Nokdhes YN, Patthamalai P, Tantrapornpong P, Suphatsathienkul P, Apinuntham C, Yan C, Nanchaipruek Y, Thongjaroensirikul P, Maneeprasopchoke P, Techapichetvanich T, Eimpunth S, Manuskiatti W, Thanachaipiwat S, Panich U (2023) A pilot study comparing the efficacy of autologous cultured fibroblast injections with hyaluronic acid fillers for treating nasolabial folds. Sci Rep 13:6616 - DOI - PubMed - PMC

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Post Hoc Non-inferiority Analysis of the Efficacy of Poly-L-Lactic Acid Filler (Gana V versus Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Randomized, Split-Face Controlled Trial

Affiliations

Post Hoc Non-inferiority Analysis of the Efficacy of Poly-L-Lactic Acid Filler (Gana V versus Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Randomized, Split-Face Controlled Trial

Authors

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Conflict of interest statement

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