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

NCT ID: NCT05997654

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2023-07-06

Brief Summary

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.

Conditions

Skin Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MEDGEL ANTIAGE

Intervention Type: DEVICE

The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.

Interventions

MEDGEL ANTIAGE

The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medcin Instituto da Pele Ltda

UNKNOWN

Sponsor Role: collaborator

Silimed Industria de Implantes Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medcin Instituto da Pele Ltda

Osasco, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EN22-0300-01

Identifier Type: -

Identifier Source: org_study_id