CTRI/2011/04/001670已完成未知
CLINICAL EVALUATION OF THE CUTANEOUS,OCULAR AND COSMETIC ACCEPTABILITY OF A SKIN FOUNDATION APPLIEDUNDER NORMAL CONDITIONS OF USE, FOR FOUR WEEKS, BY 60 ADULTSUBJECTS- USE TEST UNDER DERMATOLOGICAL AND OPHTHALMOLOGICALCONTROL .
OREA0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Sex: female.
- •? Age: 18 ? 45 years old.
- •? Subject with all type of skin on the face.
- •? Subject usually wearing fairness cream.
- •? Subject with sensitive skin (50% of the subjects)
- •?Subject with normal eyes (10 subjects only)
- •?Subject with sensitive eyes (20 subjects only)
- •? Subject wearing contact lenses (20 subjects only)
- •? Subject having given freely and expressly their informed consent, cooperative and aware
- •of the necessity and duration of the controls so that perfect adhesion to the protocol can
- •be expected.
- •? Subject who is able to read and understand documents transmitted (consent and
- •information form).
- •? Subject having an official domicile.
- •? Subject accepting not to apply cosmetic products other than those she usually applies on
- •and at their usual frequency of application.
- •? Subject having access to health services.
排除标准
- •Subject who is pregnant or nursing or who is planning a pregnancy during the study,
- •? Current use of immunosuppressive drugs and/or an organ transplant,
- •? Current use of topical or systemic anti-inflammatory drugs for a defined medical condition,
- •e.g. aspirin, ibuprofen, corticosteroids,
- •? Application within the last two months of any anti-inflammatory drug to skin area to be
- •used in studying,
- •? Insulin-dependent diabetes,
- •? Currently receiving allergy injections, final injection within the last week, or expecting to
- •begin injections during the course of the study,
- •? Immune deficiency or autoimmune disease,
- •? Skin disorders affecting the study area which, in the investigators? judgment, would
- •interfere with grading / assessment of skin response (e.g. acne, psoriasis, disorders of
- •pigmentation, scars, hyperhidrosis, etc, ?),
- •? Subjects with any skin disorder that could compromise evaluation of skin reactions,
- •? Subject having ocular pathology other than the one which involves allergy to some
- •substance thereby causing sensitive eyes.
- •? Vaccination during the three weeks preceeding the study or intention to be vaccinated
- •during the course of the study,
- •? A condition or medication which, in the investigator?s judgment, makes the subject
- •ineligible or places the subject at undue risk,
- •? Current participation in another clinical study of any kind,
- •? Subject who is unwilling or unable to give informed consent or to otherwise comply with
- •protocol requirements,
- •? Subject who cannot be contacted in case of emergency,
- •? Febrile disease in the three days preceding the study.
- •? Personnel of the investigating laboratory
研究者
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