The aim of the study is to verify safety and performance of Semical dermal fillers according to real-world data.
This study is a single-center, open label clinical follow-up study. The records of volunteers who were treated with Semical brand dermal fillers on the face at the research center and whose photographs are keps in the researcher's records will be evaluated retrospectively by the principle investigator and an independent evaluator. Volunteers who were used in accordance with the current intended use declared by the manufacturer of Semical Fine, Plus, Ultra Dermal Fillers and Mesolifter as applied in routine practice by the researcher may be included. The dermal filler application must have been applied to the necessary and determined facial areas, expectations, product safety requirements, and skin structure, with the technique deemed appropriate by the researcher. In order to obtain optimal aesthetic results, an optional touch-up application may have been made 4 weeks after the first application.
Study Type
OBSERVATIONAL
Enrollment
80
Semical Dermal Filler Fine Semical Dermal Filler Plus Semical Dermal Filler Ultra
Stabilized hyaluronic acid with NONASEM Technology. Application with Multi-Aesthetic Point Technique (MAPs)
Akdeniz University Hospital Dermatology Department Cosmetology Clinic
Antalya, Turkey (Türkiye)
GAIS
Change of Global Aesthetic Improvement Scale evaluated by patient, investigator and independent rater
Time frame: From baseline to immediately after injection, 3 months, 6 months, 9 months
WSRS
Change of Wrinkle Severity Rating Scale (WSRS) evaluated by patient, investigator and independent rater
Time frame: From baseline to immediately after injection, 3 months, 6 months
Satisfaction of volunteer
Evaluation of before and after results by visual analogue scale
Time frame: From baseline to immediately after injection, 3 montsh, 6 months
Ease of use
Investigator's assessment for ease of use of the product
Time frame: From baseline to immediately after injection, 3 months, 6 months
Injection pain
Pain perception with visual analogue scale (VAs) during and 15 minutes after injection
Time frame: During injection and 15 minutes after injection
Adverse events
Tolerability of the application by evaluation of severity and intensity of the adverse events
Time frame: throughout the entire study
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