RBR-437fmbz已完成1 期
Assessment of cutaneous and genital mucosa acceptability of a topical product under normal conditions of use
Allergisa Pesquisa dermato-cosmética ltda0 个研究点开始时间: 2022年6月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
During the study, only 01 participant had a feeling of gynecological discomfort probably related to the use of the investigational product, but of mild intensity, representing 2.9% of the population considered for the safety assessment. No participant showed signs of inflammation, edema, abrasions and de-epithelialization of the vaginal mucosa. Therefore, the investigational product can be considered safe under the evaluated conditions.The claims Gynecologically Tested and Clinically Tested can be sustained.
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 70Y（—）
- 性别
- Female
入选标准
- •Healthy research participants; intact skin in the test region; agreement to adhere to the study procedures and requirements and to attend the institute on the day(s) and time(s) determined for the assessments; ability to consent to their participation in the study; age from 18 to 70 years; female survey participants
排除标准
- •Pregnancy or breastfeeding, having a menstrual period at the time of the study visits, skin pathology in the area of ??application of the product, type 1 diabetes Mellitus, insulin-dependent diabetes, presence of complications due to diabetes (retinopathies, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, necrobiosis lipoidica, granuloma annulare, opportunistic infections);
- •history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma, immune failure, Current use of the following topical or systemic medications: corticosteroids, immunosuppressants and antihistamines, skin diseases: vitiligo, psoriasis, atopic dermatitis, history of reaction to the category of product tested, other diseases or medications that may directly interfere with the study or put the health of the research participant at risk
研究者
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