A skin whitening efficacy and safety study in adult human male subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Clinical Evaluation using skin fairness score
研究概览
简要总结
A Randomized, Placebo controlled, Investigator/Evaluator blind, Parallel twice daily home use study in healthy adult human male subjects. The study duration is 4 week application of Men’s Skin whitening cream (Cadila Healthcare Limited, India) and Placebo in 60 subjects. Primary efficacy measures are (1) Clinical evaluation using skin fairness score (2) Skin fairness assessment using Minolta Chromameter through Lab scale (3) Self evaluation questionnaire to evaluate the product efficacy and sensorial properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age:18-45 years; both inclusive 2)Sex:Male 3)Volunteer is in good physical health as determined by the Investigator/Co-investigator.
- •Volunteer is willing and able to follow the study directions, to participate in the study, returning for all specified visits, and to apply the product only to the part of the areas as per instructions.
- •Volunteers, who are willing to avoid sun bathing, swimming, prolong sun exposure or artificial UV rays during the study.
- •Able to communicate effectively with study personnel.
- •Able to understand and provide written informed consent to participate in the study.
排除标准
- •Volunteers with acne, skin infections over face, widespread active dermatitis or dermatitis on test area.
- •Volunteers with allergies to cosmetics, moisturizers, and whitening/bleaching agents.
- •Volunteer who has sunburned, chapped, or irritated skin or open wounds on test sites.
- •Volunteer who are willing to continue any other personal care products containing whitening/bleaching properties during study period.
- •Volunteer who are swimmers.
- •History or presence of Diabetes.
- •Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, acne, eczema, atopic dermatitis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. porphyria).
- •A positive test result for HIV antibody.
- •Participation in a study involving the same test area within the last 30 days.
- •Volunteer who has a condition or is taking or has taken a medication which, in the investigator’s judgment, makes the volunteer ineligible or places the volunteer at undue risk.
结局指标
主要结局
1. Clinical Evaluation using skin fairness score
时间窗: 1. Baseline visit | 2. Week 1 | 3. Week 2 | 4. Week 4
2. Self Evaluation questionnaire to evaluate the product efficacy and sensorial properties
时间窗: 1. Baseline visit | 2. Week 1 | 3. Week 2 | 4. Week 4
3. Assessment of skin fairness using Minolta Chromameter
时间窗: 1. Baseline visit | 2. Week 1 | 3. Week 2 | 4. Week 4
次要结局
- Clinical evaluation for tolerance and subject compliance to therapy(Week 1, 2, 3 and 4)