Medcin Instituto da Pele Ltda
Osasco, São Paulo, 06023-070, Brazil
NCT Number: NCT05997654
The study investigates the safety and effectiveness of SILIMED® brand MEDGEL ANTIAGE with indication for improvement of the appearance of wrinkles and general aspects of the skin.
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Notify Me30 year–55 year
Female
Interventional
Not applicable
Osasco, São Paulo, 06023-070, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.
Time frame: 28 days
Absence of risk of irritation and capture sensations of discomfort in the studied population through dermatological clinical evaluations before and after continuous use of the experimental product.
Time frame: 1h, 2h, 4h, 6h, 8h and after 28 days
Evaluate the effectiveness in changing skin hydration, through measurements by the CORNEOMETER® equipment after 1h, 2h, 4h, 6h and 8h of product contact with the skin and after 28 days of continuous use.
Time frame: Before use and after 28 days of continuous use
Evaluate the effectiveness of the investigational product in changing % of melanic and vascular dark circles through photographic recording by the VISIA® equipment and image analysis by Image Pro Plus, before use (D0) and after continuous use (D28).
Time frame: Before use and after 28 days of continuous use
Evaluate the effectiveness of the investigational product in changing skin firmness and elasticity through instrumental measurements by the CUTOMETER® equipment, before use (D0) and after continuous use (D28).
Time frame: Before use and after 28 days of continuous use
Evaluate the effectiveness of the investigational product in changing furrows and wrinkles depth through photographic records by the PRIMOS® equipment, before use (D0) and after continuous use (D28).
Time frame: Before use and after 28 days of continuous use
Evaluate the satisfaction with the investigational product from the point of view of the target population through a subjective questionnaire using a standardized 05-point scale answered before (D0) and after continuous use (D28).
Silimed Industria de Implantes Ltda
Industry
Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin - Clinical, Instrumental and Subjective Study
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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