Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study
Summary Background Hyaluronic acid (HA) fillers and poly‐L‐lactic acid (PLA) fillers are frequently used to correct facial wrinkles. Aim To compare the efficacy and safety of a novel injectable poly‐L‐lactic acid (PLA) filler and a well‐studied biphasic HA filler for the treatment of moderate to sev...
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| Published in | Clinical and experimental dermatology Vol. 40; no. 2; pp. 129 - 135 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Blackwell Publishing Ltd
01.03.2015
Oxford University Press |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Summary
Background
Hyaluronic acid (HA) fillers and poly‐L‐lactic acid (PLA) fillers are frequently used to correct facial wrinkles.
Aim
To compare the efficacy and safety of a novel injectable poly‐L‐lactic acid (PLA) filler and a well‐studied biphasic HA filler for the treatment of moderate to severe nasolabial folds.
Methods
In this multicentre, randomized, evaluator‐blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events.
Results
At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases.
Conclusions
PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. |
|---|---|
| AbstractList | Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles.
To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds.
In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events.
At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases.
PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. Summary Background Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. Aim To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds. Methods In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events. Results At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases. Conclusions PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles.BACKGROUNDHyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles.To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds.AIMTo compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds.In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events.METHODSIn this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events.At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases.RESULTSAt week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases.PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds.CONCLUSIONSPLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. Summary Background Hyaluronic acid (HA) fillers and poly‐L‐lactic acid (PLA) fillers are frequently used to correct facial wrinkles. Aim To compare the efficacy and safety of a novel injectable poly‐L‐lactic acid (PLA) filler and a well‐studied biphasic HA filler for the treatment of moderate to severe nasolabial folds. Methods In this multicentre, randomized, evaluator‐blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events. Results At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases. Conclusions PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. |
| Author | Lee, Y. Won, C. H. Hyun, M. Y. No, Y. A. Kim, M. N. Hong, C. K. Chang, S. E. Yoo, K. H. Kim, B. J. |
| Author_xml | – sequence: 1 givenname: M. Y. surname: Hyun fullname: Hyun, M. Y. organization: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea – sequence: 2 givenname: Y. surname: Lee fullname: Lee, Y. organization: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea – sequence: 3 givenname: Y. A. surname: No fullname: No, Y. A. organization: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea – sequence: 4 givenname: K. H. surname: Yoo fullname: Yoo, K. H. organization: Department of Dermatology, Catholic Kwandong University International ST.Mary's Hospital, Incheon, South Korea – sequence: 5 givenname: M. N. surname: Kim fullname: Kim, M. N. organization: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea – sequence: 6 givenname: C. K. surname: Hong fullname: Hong, C. K. organization: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea – sequence: 7 givenname: S. E. surname: Chang fullname: Chang, S. E. organization: Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea – sequence: 8 givenname: C. H. surname: Won fullname: Won, C. H. organization: Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea – sequence: 9 givenname: B. J. surname: Kim fullname: Kim, B. J. email: : Dr Beom Joon Kim, Department of Dermatology, Chung-Ang University Hospital, 224-1 Heukseok-dong, Dongjak-gu, Seoul 156-755, Korea, beomjoon@unitel.co.kr organization: Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea |
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| Copyright | 2014 British Association of Dermatologists 2014 British Association of Dermatologists. Copyright © 2015 British Association of Dermatologists |
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| References_xml | – reference: Christensen L, Breiting V, Janssen M et al. Adverse reactions to injectable soft tissue permanent fillers. Aesthetic Plast Surg 2005; 29: 34-48. – reference: Humble G, Mest D. Soft tissue augmentation using sculptra. Facial Plast Surg 2004; 20: 157-63. – reference: Greco TM, Antunes MB, Yellin SA. Injectable fillers for volume replacement in the aging face. Facial Plast Surg 2012; 28: 8-20. – reference: Vleggaar D, Bauer U. Facial enhancement and the European experience with Sculptra (poly-l-lactic acid). J Drugs Dermatol 2004; 3: 542-7. – reference: Lowe NJ. Optimizing poly-L-lactic acid use. J Cosmet Laser Ther 2008; 10: 43-6. – reference: Brady JM, Cutright DE, Miller RA, Barristone GC. Resorption rate, route, route of elimination, and ultrastructure of the implant site of polylactic acid in the abdominal wall of the rat. J Biomed Mater Res 1973; 7: 155-66. – reference: Gogolewski S, Jovanovic M, Perren SM et al. Tissue response and in vivo degradation of selected polyhydroxyacids: polylactides (PLA), poly(3-hydroxybutyrate) (PHB), and poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHB/VA). J Biomed Mater Res 1993; 27: 1135-48. – reference: Lacombe V. Sculptra: a stimulatory filler. Facial Plast Surg 2009; 25: 95-9. – reference: Lombardi T, Samson J, Plantier F et al. Orofacial granulomas after injection of cosmetic fillers. Histopathologic and clinical study of 11 cases. J Oral Pathol Med 2004; 33: 115-20. – reference: Woerle B, Hanke CW, Sattler G. Poly-L-lactic acid: a temporary filler for soft tissue augmentation. J Drugs Dermatol 2004; 3: 385-9. – reference: Rotunda AM, Narins RS. Poly-L-lactic acid: a new dimension in soft tissue augmentation. Dermatol Ther 2006; 19: 151-8. – reference: Carruthers A, Carey W, De Lorenzi C et al. Randomized, double-blind comparison of the efficacy of two hyaluronic acid derivatives, Restylane perlane and hylaform, in the treatment of nasolabial folds. 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poly-L-lactic acid as a filler for facial lipoatrophy in HIV-infected patients publication-title: Skin Pharmacol Physiol doi: 10.1159/000087608 – volume: 37 start-page: 768 year: 2011 ident: 10.1111/ced.12499-BIB0001|ced12499-cit-0001 article-title: Efficacy and durability of two hyaluronic acid-based fillers in the correction of nasolabial folds: results of a prospective, randomized, double-blind, actively controlled clinical pilot study publication-title: Dermatol Surg – volume: 27 start-page: 1135 year: 1993 ident: 10.1111/ced.12499-BIB0008|ced12499-cit-0008 article-title: Tissue response and in vivo degradation of selected polyhydroxyacids: polylactides (PLA), poly(3-hydroxybutyrate) (PHB), and poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHB/VA) publication-title: J Biomed Mater Res doi: 10.1002/jbm.820270904 – volume: 118 start-page: 55 issue: Suppl year: 2006 ident: 10.1111/ced.12499-BIB0007|ced12499-cit-0007 article-title: Injectable poly-L-lactic acid (Sculptra): technical considerations in soft-tissue contouring publication-title: Plast Reconstr Surg doi: 10.1097/01.prs.0000234612.20611.5a – volume: 29 start-page: 588 year: 2003 ident: 10.1111/ced.12499-BIB0012|ced12499-cit-0012 article-title: A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds publication-title: Dermatol Surg – volume: 111 start-page: 1697 year: 2001 ident: 10.1111/ced.12499-BIB0016|ced12499-cit-0016 article-title: Resorbable fixation in facial plastic and head and neck reconstructive surgery: an initial report on polylactic acid implants publication-title: Laryngoscope. doi: 10.1097/00005537-200110000-00005 – volume: 25 start-page: 95 year: 2009 ident: 10.1111/ced.12499-BIB0017|ced12499-cit-0017 article-title: Sculptra: a stimulatory filler publication-title: Facial Plast Surg doi: 10.1055/s-0029-1220648 – ident: 10.1111/ced.12499-BIB0013|ced12499-cit-0013 – volume: 10 start-page: 43 year: 2008 ident: 10.1111/ced.12499-BIB0020|ced12499-cit-0020 article-title: Optimizing poly-L-lactic acid use publication-title: J Cosmet Laser Ther doi: 10.1080/14764170701840074 – volume: 31 start-page: 1591 year: 2005 ident: 10.1111/ced.12499-BIB0010|ced12499-cit-0010 article-title: Randomized, double-blind comparison of the efficacy of two hyaluronic acid derivatives, Restylane perlane and hylaform, in the treatment of nasolabial folds publication-title: Dermatol Surg doi: 10.2310/6350.2005.31246 – volume: 13 start-page: 107 year: 2011 ident: 10.1111/ced.12499-BIB0011|ced12499-cit-0011 article-title: Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of moderate nasolabial folds: 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study publication-title: J Cosmet Laser Ther doi: 10.3109/14764172.2011.571699 – volume: 28 start-page: 8 year: 2012 ident: 10.1111/ced.12499-BIB0006|ced12499-cit-0006 article-title: Injectable 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| Snippet | Summary
Background
Hyaluronic acid (HA) fillers and poly‐L‐lactic acid (PLA) fillers are frequently used to correct facial wrinkles.
Aim
To compare the... Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. To compare the efficacy and safety of a novel... Summary Background Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. Aim To compare the... Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles.BACKGROUNDHyaluronic acid (HA) fillers and... |
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| SubjectTerms | Adult Aged Cosmetic Techniques - adverse effects Dermatologic Agents - administration & dosage Dermatologic Agents - adverse effects Female Humans Hyaluronic Acid - administration & dosage Hyaluronic Acid - adverse effects Injections - adverse effects Lactic Acid - administration & dosage Lactic Acid - adverse effects Male Middle Aged Nasolabial Fold Polyesters Polymers - administration & dosage Polymers - adverse effects Skin Aging - drug effects Viscosupplements - administration & dosage Viscosupplements - adverse effects |
| Title | Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study |
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