Status:
COMPLETED
Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin
Lead Sponsor:
Silimed Industria de Implantes Ltda
Collaborating Sponsors:
Medcin Instituto da Pele Ltda
Conditions:
Skin Aging
Eligibility:
FEMALE
30-55 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05997654
Start Date
May 17 2023
End Date
July 6 2023
Last Update
August 18 2023
Active Locations (1)
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1
Medcin Instituto da Pele Ltda
Osasco, São Paulo, Brazil, 06023-070