CTRI/2012/02/002420已完成未知
Clinical evaluation of the in vivo efficacy of a day cream product at reducing various forms of hyper pigmentation on Asian skin over 3 months in conjunction with a basic night cream, applied under normal conditions of use by adult subjects. - Not Applicable
Oriflame Research and Development Ltd0 个研究点目标入组 36 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
- 36
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
- •Healthy Indian subjects,
- •Sex: female,
- •Age: 18 â?? 65 years old,
- •Subject having at least one of the following on both the left and right profiles of the face
- •- moderate melasma
- •- a dark spot severity score of 1-3 according to the Spot Contrast scale (Skin Ageing Atlas, Asian type by Bazin and Doublet)
- •- moderate Post Acne hyperpigmentation
- •Fitzpatrick skin types III â?? V,
- •Subject not using skin lightening facial product at least 12 weeks prior to trial,
- •Subject having given freely and expressly her 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 sheet),
- •Subject accepting not to apply cosmetic products other than those she usually applies and at their usual frequency of application,
- •Subject having access to health services.
排除标准
- •Subject who is unwilling or unable to give informed consent or to otherwise comply with protocol requirements,
- •Subject who is pregnant or nursing or who is planning a pregnancy during the study,
- •Subject exhibiting active acne,
- •Subject who is acne prone,
- •Subject having started, changed or interrupted any hormonal treatment (contraceptive, HRT, thyroid) during the past 3 months or intending to change during the study,
- •Subject having taken within 12 weeks prior to the study any systemic antibiotics, steroids, or any oral anti acne medications such as retinoids within 6 months prior to 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,
- •Currently receiving allergy injections, final injection within the last week, or expecting to begin injections during the course of the study,
- •Insulin-dependent diabetes,
- •Immune deficiency or autoimmune disease,
- •Skin disorders affecting the study area which, in the investigatorâ??s judgment, would interfere with the grading / assessment of the skin response (e.g. acne, psoriasis, scars, hyperhidrosis, etc, â?¦),
- •Subjects with any skin disorder that could compromise evaluation of skin reactions,
- •Vaccination during the three weeks preceding the study or intention to be vaccinated during the course of the study,
- •Current participation in another clinical study of any kind,
- •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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