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

Skin Aging Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05997654
• Other study ID #: EN22-0300-01
• Status: Completed
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: July 6, 2023

Study information

• Verified date: August 2023
• Source: Silimed Industria de Implantes Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 6, 2023
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Aging

Intervention

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

Locations

Country	Name	City	State
Brazil	Medcin Instituto da Pele Ltda	Osasco	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Silimed Industria de Implantes Ltda	Medcin Instituto da Pele Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	% 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
Secondary	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
Secondary	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
Secondary	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