European Multicenter Prospective Study Evaluating Long-Term Safety and Efficacy of the Polycaprolactone-Based Dermal Filler in Nasolabial Fold Correction.

Autor:	Moers-Carpi M; Private Clinic, Hautok, Munich, Germany., Christen MO; Behavior, Paris, France., Delmar H; Mediti-Clinique Science et Beauté, Juan-les-Pins, France., Brun P; Private Dermatological Center, Cannes, France., Bodokh I; Private Dermatological Center, Cannes, France., Kestemont P; Mediti-Clinique Science et Beauté, Juan-les-Pins, France.
Jazyk:	angličtina
Zdroj:	Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] [Dermatol Surg] 2021 Jul 01; Vol. 47 (7), pp. 960-965.
DOI:	10.1097/DSS.0000000000002978
Abstrakt:	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 and Methods: 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. (Copyright © 2021 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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