European Multicenter Prospective Study Evaluating Long-Term Safety and Efficacy of the Polycaprolactone-Based Dermal Filler in Nasolabial Fold Correction.
Dermatol Surg
; 47(7): 960-965, 2021 07 01.
Article
em En
| MEDLINE
| ID: mdl-33731572
ABSTRACT
BACKGROUND:
Age-related changes affecting facial areas can be corrected using minimally invasive dermal fillers. The use of polycaprolactone-dermal filler (PCL-filler) in aesthetics is increasing.OBJECTIVE:
To evaluate the long-term safety and efficacy of the PCL-filler, in a European, multicenter, prospective study. MATERIALS ANDMETHODS:
Subjects (n = 90) with moderate/severe nasolabial folds (Wrinkle Severity Rating Scale [WSRS] 3 to 4) were treated on Day 0 with a single injection of similar volume on each side; safety and efficacy assessments were performed over an 18-month period. In 1 of the 3 study centers, safety was evaluated at 30 months.RESULTS:
At Month 12 (M12; primary endpoint), 84% of subjects showed a ≥1-point improvement on the WSRS (M6 92%; M18 64%). From the investigator/subject's evaluation, from Day 7 to M12, Global Aesthetic Improvement was reported for >90% of subjects, with the effect maintained for up to 18 months in >80% of patients. Subjects/investigators reported high satisfaction and skin quality improvement. Most of the immediate injection-site reactions disappeared after 2 to 4 days. No severe or unexpected adverse events were reported.CONCLUSION:
This study demonstrated the long-term safety and efficacy of the PCL-filler, with safety confirmed for up to 30 months.
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Poliésteres
/
Técnicas Cosméticas
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Sulco Nasogeniano
/
Preenchedores Dérmicos
Tipo de estudo:
Clinical_trials
/
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
País/Região como assunto:
Europa
Idioma:
En
Revista:
Dermatol Surg
Assunto da revista:
DERMATOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Alemanha