CTRI/2012/07/002771已完成2 期
A Phase II, randomized, double blind, placebo controlled, monocentric study to evaluate the efficacy and safety of Anti Ageing and Regeneration Cream in Healthy Human Volunteers
Sami Labs0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- •Subjects in generally good health
- •Subjects of skin types III, IV, and V.
- •Subjects age group 30 - 55 years
- •Subjects willing to give a written informed consent and come for a regular follow up.
- •Subject willing to abide by and comply with the study protocol
- •Subject has not participated in a similar investigation in the past four weeks.
- •Subjects having visible fine lines and wrinkles in periorbital area (Crowâ??s feet),nasolabial areas, forehead ,and perioral regions of the face
- •Subjects having mild to moderate nasolabial folds
- •Subjects having apparent mild to moderate crowâ??s feet in unanimated face
- •Subjects who have not under gone any facial anti ageing procedures (e.g. Botulinum toxin, dermal filler injections, laser resurfacing) in the past 3 months.
- •Subject should be willing to abstain from spa treatments/facials during the study period
排除标准
- •A known history or present condition of allergic response to any cosmetic products.
- •Subjects having severe photoaging.
- •Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings.
- •Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
- •Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
- •Subjects not willing to discontinue other topical anti ageing, anti wrinkle facial products.
- •Subjects who are pregnant, lactating or nursing.
- •Hypersensitivity to any component of the tested products.
- •History of intense sun exposure.
- •Chronic illness which may influence the cutaneous state.
- •Subject participating in any other cosmetic or therapeutic trial.
- •Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
研究者
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