Evaluation of the Safety and Effectiveness of the Investi... | NCT05997654

Status Module

Name	Class
Medcin Instituto da Pele Ltda	UNKNOWN

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Instrumental procedures and safety and efficacy assessments	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MEDGEL ANTIAGE	Device	The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.	Instrumental procedures and safety and efficacy assessments

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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