RBR-94vwv2招募中未知
Evaluation of Dermal and Gynecological Acceptability of a Medical Device (Irritability and Sensitization in the Genital Mucosa) and Evaluation of the Moisturizing Potential by Corneometry
试验速览
- 阶段
- 未知
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 45Y 至 65Y（—）
- 性别
- Female
入选标准
- •Healthy women complaining of vaginal dryness; Age range between 45 and 65 years; Intact skin in the region of product analysis; No history of reaction to topical products
排除标准
- •Pregnancy or risk of gestation and or lactation; pathologies and or cutaneous lesions such as psoriasis, sensitive skin, skin cancer, rosacea, atopic dermatitis or other medical criteria to be considered at the time of evaluation; hyperpigmentation in the area of Test that interfere in the evaluation of possible reactions vascular malformations, scars, increased pilosity and large amount of nerves; Active cutaneous pathologies and or lesions local and or disseminated in the evaluation area; use of the following Topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatories, and corticosteroids up to 30 days before selection or considering immunosuppressants, the interval should be 3 months before selection; Decompensated endocrinopathies; Immunosuppression by drugs or active diseases; Relevant clinical history or current evidence of abuse of alcohol or other drugs; Aesthetic or dermatological treatment in the evaluation area up to 04 weeks before selection; Alteration of hygiene habits up to 04 weeks before selection, such as: Alteration of brand and type of body and intimate soaps and etc. ; Atopic or allergic antecedents to category products; Known history or suspected intolerance to Products of the same category; Cutaneous markers in the experimental area that interfere in the evaluation of possible cutaneous reactions vascular malformations, scars, increased pilosity and nevus in large quantity; Participants with Known congenital or acquired immunodeficiency; Professionals directly involved in conducting the present study both from the research center and from the sponsor; Other conditions considered by the appraiser physician as reasonable for Disqualification of the study's participation. If yes, it should be described under observation in the clinical form.
研究者
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