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Completed

NCT Number: NCT05997654

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

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.

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Key information

Conditions

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medcin Instituto da Pele Ltda

Osasco, São Paulo, 06023-070, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDGEL ANTIAGE

Device

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

Primary outcomes

  1. Frequency of adverse events

    Time frame: 28 days

    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.

Secondary outcomes

  1. Change in skin hydration

    Time frame: 1h, 2h, 4h, 6h, 8h and after 28 days

    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.

  2. % of change in melanic and vascular dark circles

    Time frame: Before use and after 28 days of continuous use

    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).

  3. Change in skin firmness and elasticity

    Time frame: Before use and after 28 days of continuous use

    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).

  4. Change in furrows and wrinkles depth

    Time frame: Before use and after 28 days of continuous use

    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).

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

    Time frame: Before use and after 28 days of continuous use

    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).

Sponsors and collaborators

Lead sponsor

Silimed Industria de Implantes Ltda

Industry

Collaborators

  • Medcin Instituto da Pele Ltda

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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