CTRI/2017/06/008809已完成未知
Monocentric, double blinded, placebo controlled, randomized parallel study to evaluate the effect of INDUS1520 and INDUS1530 on facial skin and their in- use tolerance in women
Indus Biotech Private Limited0 个研究点目标入组 72 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
- 72
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
- •a)Voluntary women from 35 years to 55 years of age.
- •b)Participants with mild (Fine wrinkles and less number of lines) to moderate (Fine to moderate depth wrinkles with moderate number of lines) wrinkles in crowâ??s feet area
- •c)Participants with photo type III (Light brown, sometimes burn, Difficult to tan) and IV (Moderate brown, rare burn, tan with ease) as per the Fitzpatrick scale.
- •d)Having healthy skin on face.
- •e)Willingness to discontinue the use of other cosmetic products on face during the course of the study.
- •f)Accepting not to use products with the same end benefit during the entire study duration.
- •g)Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •h)Having signed a Consent Form, after being informed orally and in writing of all information concerning the study procedures and study objectives.
- •i)Willingness to avoid intense UV exposure as far as possible for the entire study duration
排除标准
- •a)Pregnant women by UPT / lactating women / women planning pregnancy.
- •b)Any skin disease on face
- •c)Any cutaneous conditions on test site (scars, moles, papules etc).
- •d)Hypersensitivity, allergy antecedent (to any cosmetic product, raw material).
- •e)Chronic illness which may influence the study results.
- •f)Any clinically significant systemic or cutaneous disease, which may interfere with study procedures.
- •g)For whom the Investigator considers that he/she will not be compliant with study procedures.
- •h)Participants on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •i)Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
研究者
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