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

NCT05997654 | Completed

• 1 other identifier: EN22-0300-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• Change in skin hydration

  1h, 2h, 4h, 6h, 8h and after 28 days

• % of change in melanic and vascular dark circles

  Before use and after 28 days of continuous use

• Change in skin firmness and elasticity

  Before use and after 28 days of continuous use

• Change in furrows and wrinkles depth

  Before use and after 28 days of continuous use

• Satisfaction assessed by a subjective questionnaire using a standardized 05-point scale

  Before use and after 28 days of continuous use

Study Arms (1)

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

MEDGEL ANTIAGE DEVICE

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

Instrumental procedures and safety and efficacy assessments

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Silimed Industria de Implantes Ltda: lead
• Medcin Instituto da Pele Ltda: collaborator

Study Sites (1)

Medcin Instituto da Pele Ltda

Osasco, São Paulo, 06023-070, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 18, 2023
• Study Start: May 17, 2023
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)