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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-linked Hyaluronic Acid Dermal Filler | Products: Semical Dermal Filler- Fine Semical Dermal Filler - Plus Semical Dermal Filler - Ultra Cross-linked hyaluronic acid injection for wrinkle correction and/or reshaping of nasolabial folds, marionette lines, crow's feet, perioral lines, periorbital lines, cheek and lip augmentation |
| |
| Stabilized Non Cross-linked Hyaluronic Acid Mesolifter | Semical Mesolifter injection for rejuvenation and revitalization of facial skin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cross-linked hyaluronic acid | Device | Semical Dermal Filler Fine Semical Dermal Filler Plus Semical Dermal Filler Ultra |
|
| Measure | Description | Time Frame |
|---|---|---|
| GAIS | Change of Global Aesthetic Improvement Scale evaluated by patient, investigator and independent rater | From baseline to immediately after injection, 3 months, 6 months, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| WSRS | Change of Wrinkle Severity Rating Scale (WSRS) evaluated by patient, investigator and independent rater | From baseline to immediately after injection, 3 months, 6 months |
| Satisfaction of volunteer |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male volunteers aged 18 and over who had facial filler application with Semical brand hyaluronic acid dermal fillers at the Akdeniz University Hospital Cosmetology Polyclinic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akdeniz University Hospital Dermatology Department Cosmetology Clinic | Antalya | 07100 | Turkey (Türkiye) |
Not allowed by local regulations
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| Mesolifter | Device | Stabilized hyaluronic acid with NONASEM Technology. Application with Multi-Aesthetic Point Technique (MAPs) |
|
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Evaluation of before and after results by visual analogue scale
| From baseline to immediately after injection, 3 montsh, 6 months |
| Ease of use | Investigator's assessment for ease of use of the product | 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 | During injection and 15 minutes after injection |
| Adverse events | Tolerability of the application by evaluation of severity and intensity of the adverse events | throughout the entire study |