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

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

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 Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Device: MEDGEL ANTIAGE

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Osasco, São Paulo, Brazil, 06023-070
      • Medcin Instituto da Pele Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Instrumental procedures and safety and efficacy assessments; 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; The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Silimed Industria de Implantes Ltda
• Collaborators: Medcin Instituto da Pele Ltda

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Actual): July 6, 2023
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EN22-0300-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No