CTRI/2017/01/007731已完成不适用
Efficacy evaluation of cosmetic formulations in conferring anti-skin aging benefits in healthy human volunteers
ITC Life Science and Technology Centre1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年8月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To evaluate the safety and efficacy of the investigational products (IP) in reducing the facial wrinkles and fine lines in comparison to the baseline and a reference product
研究概览
简要总结
Double blind, randomized, comparative, parallel design, single centre trial. Total 120 healthy human adult male and female subjects in 1:3 ratio. 35+5 subjects in each of the 3 treatment groups with 10 men and 30 women in each group. Subjects will be assigned the investigational product to use on whole face twice daily. This will be an 12 weeks study. All the subjects will be assessed on Baseline (week 0), week 2, week 4, week 6, week 8, week 10 and week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subject is willing to give a written informed consent •Subject is a healthy adult (male or female) in the age range of 35- 60 years •Subject has a wrinkle score between 2 and 4 (moderate/ medium wrinkles) as per the photonumeric scale •Subject has at least 2 dark spots on face that are age spots /lentigines marks other than Mealsma or Chloasma •In case of having used fairness product in the near past Subject is willing to undergo a wash out period of 1 week, wherein they would abstain from applying any product other than the provided cleanser on face.
- •â€¢Subject who is willing to comply with the study protocol and abide by the study restrictions such as refraining from using cosmetic or medicinal or ayurvedic or natural products on face and also willing to abstain from undergoing any facial treatments such as facial masks, packs, waxing, threading etc either at home or at parlour other than the provided cream during the entire study course and visiting the centre for regular follow up visits.
- •â€¢Female subjects of reproductive age group willing to undergo UPT at time of screening visit.
排除标准
- •â€¢Female subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course.
- •â€¢Subject with a known history or present condition of allergic response to any cosmetic products, toiletries or their ingredients including fragrance.
- •â€¢Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results •Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti-acne medication) within past 4 weeks or any topical facial medication within 2 weeks before the start of the study, which could compromise the study.
- •â€¢Subject has not participated in a similar clinical investigation in the past three months or applied skin lightening product on face or undergone a treatment like facial packs, bleaching in the past two weeks.
- •â€¢Subject with excessive facial hair or scars, which could interfere with evaluation.
- •â€¢Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test.
结局指标
主要结局
To evaluate the safety and efficacy of the investigational products (IP) in reducing the facial wrinkles and fine lines in comparison to the baseline and a reference product
时间窗: Week 0, week 2, week 4, week 6, week 8, week 10 & week 12
次要结局
- To monitor the safety of long term use of anti-skin aging formulations on all skin types.(To evaluate the overall changes in skin condition upon usage of the IP in comparison to baseline and a reference product)
研究者
研究点 (1)
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