Clinical Study, Opened, of Cutaneous Acceptability of a Topic Product in Normal Conditions of Use and Evaluation of the Effectiveness Through the Self Awareness of the Research, of Clinical Evaluations and Instrumental Measurements
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 35
- 主要终点
- Skin acceptability through the self perception of patients.
研究概览
简要总结
The measured product in this research is a product for topical use, Laboratoires Mercurochrome Reparador e Protetor. The expected benefit to the use of the product is the improvement in skin hydration as measured by self perception of participant research and clinical evaluation and improvement in local microcirculation, assessed by instrumental measurements in feet of the study participants.
详细描述
The objectives of this study is to verify the skin acceptability through the non-occurrence of adverse events and cutaneous sensations of discomfort, evaluate the moisturizing efficacy of the product through self perception of research participants and dermatological clinical evaluation to assess the improvement in local microcirculation by performing of instrumental measurements in the feet of diabetic participants, product Laboratoires Mercurochrome Repairer and Protector referred by LM FARMA INDUSTRIAL LTDA.
For this research, will be recruited up to 35 research participants who meet the inclusion / exclusion described in items 9.4 and 9.5 of the research protocol, to achieve a number of completion of 30 participants. Be recruited participants from both sexes, aged 18 and 65, which have dry skin on the feet and they are people with diabetes whose condition is stabilized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants healthy research;
- •Intact skin on feet - grade 0 in the Wagner scale;
- •Agreement to adhere to the procedures and requirements of the study and attend to the Office (s) day (s) and time (s) set (s) for evaluations;
- •Ability to consent to participate in writing;
- •Age 18 to 65 years;
- •Research Participants of both sexes - including at least three men;
- •Introducing dry skin on feet - dermatological proof.
- •Participants with diabetes whose condition is stabilized
排除标准
- •Pregnancy and lactation; skin pathology in the product application area;
- •immune impairment;
- •Current use of these medications for topical or systemic use: corticoid, immunosuppressants, antihistamines, anticoagulants or birth;
- •Skin diseases: psoriasis, vitiligo, atopic dermatitis;
- •History of reaction to the category of the product tested;
- •Other diseases or medications that may interfere directly in the study or to endanger the health of the research participant.
结局指标
主要结局
Skin acceptability through the self perception of patients.
时间窗: 2 months
Measure the skin acceptability through the self perception of patients with the daily use of the product adding in a questionnaire the product effectiveness.
次要结局
- Instrumental Performance Measures(2 months)