NCT05997654已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Frequency of adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Frequency of adverse events
时间窗: 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.
次要结局
- 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)
研究者
研究点 (2)
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