Polycaprolactone for the correction of nasolabial folds: a 24-month, prospective, randomized, controlled clinical trial.
Dermatol Surg
; 39(3 Pt 1): 457-63, 2013 Mar.
Article
em En
| MEDLINE
| ID: mdl-23350617
ABSTRACT
BACKGROUND:
In this study, we examined two polycaprolactone (PCL)-based dermal filler formulas (PCL-1; PCL-2) for safety, patient satisfaction, likelihood to return, efficacy, and duration of correction.OBJECTIVE:
This 40-patient, 24-month, prospective, randomized, controlled study evaluated the efficacy, safety, longevity, and volume of two PCL formulas for correction of nasolabial folds.METHODS:
Patients enrolled in a medical clinic in Europe received two injections 1 month apart and returned at 3, 6, 9, 12, 15, 18, and 24 months for blinded patient evaluation using accepted aesthetic rating scales.RESULTS:
At 12 months, the efficacy outcomes on Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale (GAIS) of PCL-1 and PCL-2 were consistently maintained, with sustained improvement in 90% and 91.4% of patients, respectively. At 24 months, PCL-2 was found to be more effective than PCL-1 with respect to GAIS and WSRS, showing sustained improvement for the entire 2-year study period (linear p = .52; quadratic p > .99). Patient satisfaction at 24 months was 72.4% for PCL-1 and 81.7% for PCL-2. Both products were found to be safe and well tolerated.CONCLUSIONS:
PCL-1 and PCL-2 are safe and have sustained efficacy and high patient satisfaction, with PCL-2 demonstrating longer-lasting results than PCL-1.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Poliésteres
/
Técnicas Cosméticas
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Sulco Nasogeniano
Tipo de estudo:
Clinical_trials
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Observational_studies
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Dermatol Surg
Assunto da revista:
DERMATOLOGIA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Alemanha