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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
33
The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.
Medcin Instituto da Pele Ltda
Osasco, São Paulo, Brazil
Frequency of adverse events
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: 28 days
Change in skin hydration
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: 1h, 2h, 4h, 6h, 8h and after 28 days
% of change in melanic and vascular dark circles
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
Change in skin firmness and elasticity
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
Change in furrows and wrinkles depth
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
Satisfaction assessed by a subjective questionnaire using a standardized 05-point scale
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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).
Time frame: Before use and after 28 days of continuous use