An Open-Label, Single-Arm, Prospective Clinical Study to Evaluate Efficacy and Safetyof Oral Glutathione capsule as a skin-lightening agent in Subjects with dark skin and Hyperpigmentation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The percentage of subjects with Skin lightening over baseline at least one tone light at 30 days of treatment using Fitzpatrick scale the from baseline visit to end of treatment visit.
研究概览
简要总结
The study is designed as Open label, singlearm, prospective, interventional and observational study. All the subjects willreceive Glutathione capsule 600 mg as a test product. Subjects fulfilling theinclusion and exclusion criteria will be enrolled in the study. Enrolledsubjects will be under treatment for 4 weeks, following up at day 15 and day30.
Parameters of Skin tone and Melaninindices and quality of life questionnaires will be assessed at baseline and atday 30. Safety parameters like hematology and biochemistry will be assessed atbaseline and at day 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy Volunteers, men or women, from 18 to 60 years old.
- •2.Having given their written, free and informed consent.
- •4.Working indoor office jobs (for minimum 8 hours).
排除标准
- •1.Personal or family history of skin cancer, especially melanoma.
- •2.Consumption of any preparations containing glutathione within 1 month of enrolment.
- •3.Use of any topical skin brightening or whitening preparations within 1 month of enrolment.
- •4.Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas.
- •5.A pregnant or breastfeeding mother.
- •6.Personal history of drug allergy or skin disorder due to side effects of oral therapy.
- •7.Alcoholics and subjects with substance abuse.
- •8.Subjects who have participated in other trial within last 3 months.
- •9.Any other condition which the principal investigator thinks may jeopardize the study.
结局指标
主要结局
The percentage of subjects with Skin lightening over baseline at least one tone light at 30 days of treatment using Fitzpatrick scale the from baseline visit to end of treatment visit.
时间窗: Day 1 to Day 30
次要结局
- The numbers of subjects with Decreased Melanin Index(Day 1 to Day 30)
- Mean change in Liver function test(Day 1 to Day 30)
- Mean change in Plasma Glutathione level(Day 1 to Day 30)
- Mean change in Melanin indices(Day 1 to Day 30)
- Overall improvement in Skin tone by Physician’s Global Assessment(Day 1 to Day 30)
- Overall improvement in Skin tone by Patient’s Global Assessment(Day 1 to Day 30)