NCT05997654CompletedNot Applicable
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
Silimed Industria de Implantes Ltda1 site in 1 country33 target enrollmentStarted: May 17, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Frequency of adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: MEDGEL ANTIAGE (Device)
Outcomes
Primary Outcomes
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
- Change in furrows and wrinkles depth(Before use and after 28 days of continuous use)
- % of change in melanic and vascular dark circles(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)
- Change in skin hydration(1h, 2h, 4h, 6h, 8h and after 28 days)
- Change in skin firmness and elasticity(Before use and after 28 days of continuous use)
Investigators
Study Sites (1)
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