Effectiveness and Safety of Sculptra Poly-L-Lactic Acid Injectable Implant in the Correction of Cheek Wrinkles.
J Drugs Dermatol
; 23(1): 1297-1305, 2024 Jan 01.
Article
em En
| MEDLINE
| ID: mdl-38206151
ABSTRACT
BACKGROUND:
The current study evaluated the effectiveness and safety of Sculptra injectable poly-L-lactic acid (PLLA-SCA) treatment in correcting cheek wrinkles compared with a no-treatment control.METHODS:
Male/female immune-competent adults (aged >21 years) with moderate/severe cheek wrinkles, graded using the Galderma Cheek Wrinkle Scale (GCWS) at rest, were randomized 21 to receive PLLA-SCA injections (150 mg; 8 mL reconstitution in sterile water for injection) + 1 mL lidocaine hydrochloride (2%), administered immediately after reconstitution, or no treatment (control). Up to 3 additional treatments were allowed at monthly intervals, and follow-up was at months 7, 9, and 12. The primary endpoint was 1-grade or greater improvement in GCWS at rest for both cheeks at month 12.RESULTS:
GCWS at rest responder rate was significantly higher with PLLA-SCA treatment versus the no-treatment control at months 7 (66.2% versus 38.6%; P=0.0043), 9 (70.6% versus 31.1%; P<0.0001), and 12 (71.6% versus 26.1%; P<0.0001). Treating investigators reported improvements in skin radiance (>95%), tighter appearance (>88%), and jawline contour (>85%). PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and firmness (91% or greater) as well as natural-looking results (85% or greater) and a desire for repeat treatment (84% or greater). Treatment-related adverse events were mostly mild in severity with no serious events related to PLLA-SCA injections.CONCLUSION:
Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and wrinkles, while improving skin quality. Effectiveness was durable over the 12-month study period with high subject-reported satisfaction, natural-looking appearance, and enthusiasm for repeat treatments. CLINICALTRIALS gov registry number NCT04124692J Drugs Dermatol. 2024;23(1)1297-1305. doi10.36849/JDD.7729.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Poliésteres
/
Celulose
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Ácido Láctico
/
Manitol
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article