Clinical trial NCT05997654: Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Lead sponsor: Silimed Industria de Implantes Ltda
Sponsor class: INDUSTRY
Collaborators: name: Medcin Instituto da Pele Ltda
First posted: 2023-08-18
Enrollment: 33
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: Frequency of adverse events
timeFrame: 28 days
Secondary outcomes:
measure: Change in skin hydration
timeFrame: 1h, 2h, 4h, 6h, 8h and after 28 days
measure: % of change in melanic and vascular dark circles
timeFrame: Before use and after 28 days of continuous use
measure: Change in skin firmness and elasticity
timeFrame: Before use and after 28 days of continuous use
measure: Change in furrows and wrinkles depth
timeFrame: Before use and after 28 days of continuous use
measure: Satisfaction assessed by a subjective questionnaire using a standardized 05-point scale
timeFrame: Before use and after 28 days of continuous use
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto da Pele Ltda
state: São Paulo
Study officials:
References: