CTRI/2018/01/011379已完成1 期
A double blinded, comparator controlled, randomized single center clinical study to evaluate the safety and efficacy of facial bleach formulations in improving and retaining skin fairness on healthy human subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 220
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
- •1.220 female & Male subjects in generally good health.
- •2.Subjects in 18 to 34 years of age group.
- •3.Subjects must have used facial bleach at least once.
- •4.Subjects with clear face without any age/dark spots.
- •5.Subjects having Chromameter reading in the range of 50.00-61.00 as average of cheeks, forehead and chin.
- •6.Out of 160 subjects, 40 with Most Sensitive Skin.
- •7.Out of 160 subjects, 40 with young and sensitive Skin.
- •8.Out of 160 subjects, 20 with wheatish Skin Complexion.
- •9.Out of 160 subjects, 40 with Fairer Skin Complexion.
- •10.Out of 160 subjects, 20 male subjects.
- •11.Subjects willing to give a written informed consent and come for regular follow up.
排除标准
- •1.Subjects with known allergies or sensitivities to cosmetic products, toiletries or its components like fragrances, preservatives, hydroquinone, vitamin C, Niacin amide, retinol, soy etc.
- •2.Currently or has been using topical retinoids, alpha-hydroxy and/or beta-hydroxy acids, hydroquinone or any whitening/Fairness preparation in any form (cleanser, toner, facial lotion, cream or soaps) within the last 1 month.
- •3.Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.
- •4.Currently or has been involved in another facial skin care clinical investigation within the last 3 months.
- •5.Subjects who have pre-existing or dormant facial dermatologic conditions (e.g., psoriasis, rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with the outcome of the study as determined by the investigator.
- •6.Subjects who have a medical history of disease or condition or a concurrent illness that could affect the outcome of the study.
- •7.Subjects with excessive facial hair or scars (including acne scars), which could interfere with expert grader and/or instrumental evaluations.
研究者
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