Akdeniz University Hospital Dermatology Department Cosmetology Clinic
Antalya, 07100, Turkey (Türkiye)
NCT Number: NCT07160777
The aim of the study is to verify safety and performance of Semical dermal fillers according to real-world data.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Antalya, 07100, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Semical Dermal Filler Fine Semical Dermal Filler Plus Semical Dermal Filler Ultra
Other names: Dermal Filler, Hyaluronic acid dermal filler
Stabilized hyaluronic acid with NONASEM Technology. Application with Multi-Aesthetic Point Technique (MAPs)
Other names: Skin booster
Time frame: From baseline to immediately after injection, 3 months, 6 months, 9 months
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
Change of Wrinkle Severity Rating Scale (WSRS) evaluated by patient, investigator and independent rater
Time frame: From baseline to immediately after injection, 3 montsh, 6 months
Evaluation of before and after results by visual analogue scale
Time frame: From baseline to immediately after injection, 3 months, 6 months
Investigator's assessment for ease of use of the product
Time frame: During injection and 15 minutes after injection
Pain perception with visual analogue scale (VAs) during and 15 minutes after injection
Time frame: throughout the entire study
Tolerability of the application by evaluation of severity and intensity of the adverse events
Semikal Technology
Industry
A Single Center Study Evaluating The Clinical Performance and Safety of Hyaluronic Acid-Based Implantable Dermal Fillers Applied to the Face
Acronym: SEMDERMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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