Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Skin Aging

Intervention / Treatment
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* Device: MEDGEL ANTIAGE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged between 30 and 55 years old; Participants with all skin types (normal, dry, combination and oily); Participants with mild to moderate signs of aging, according to Lanier's classification; Participants with melanic and/or vascular dark circles; Participants with bags around their eyes; Users of products from the same category; Intact skin in the product analysis region (face); Participants who agree NOT to use any other topical products on the test area during the study period; Agreement to comply with the trial procedures and to attend the clinic on the specified days and times; Understand, consent and sign the informed consent. Exclusion Criteria: Participants diagnosed with COVID-19 in the last 4 weeks or showing symptoms such as fever, dry cough, tiredness, body aches or other discomfort; Pregnancy/lactation or intention to become pregnant during the study period; Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticoids up to 30 days before selection or considering immunosuppressants, the interval should be 3 months before selection; Atopic or allergic history of health products; Pathologies and/or active skin lesions (local and/or disseminated) in the assessment area; Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevus, sunburn); Immunosuppression by drugs or active diseases; Decompensated endocrinopathies; Participants with known congenital or acquired immunodeficiency; Relevant medical history or current evidence of alcohol or other drug abuse; Known history or suspected intolerance to products in the same category Intense sun exposure up to 15 days before the assessment; Aesthetic or dermatological treatment in the evaluation area up to 04 weeks before selection; Professionals directly involved in carrying out this study; Other conditions considered by the evaluating physician as reasonable for disqualification from participating in the study. If yes, it should be described in observation in the clinical record

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Instrumental procedures and safety and efficacy assessments<br>Group I: 23 participants who will undergo instrumental procedures, perceived efficacy questionnaires and clinical assessments of safety and efficacy. Group II: 10 participants who will only perform perceived efficacy questionnaires and clinical assessments of safety and efficacy. | Device: MEDGEL ANTIAGE<br>* The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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). | 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). | Before use and after 28 days of continuous use | 
| Satisfaction assessed by a subjective questionnaire using a standardized 05-point scale | 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). | Before use and after 28 days of continuous use |