Oral Glutathione As A Skin Whitening Agent: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from Baseline Spot UV at 4 weeks
研究概览
简要总结
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan. Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules or placebo for 12 weeks and evaluated every 4 weeks. The main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
详细描述
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent.
The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan.
Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules (500 mg) or placebo capsules, which were identical in appearance and packaged in identical-looking containers. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Compliance was assessed by counting the remaining capsules at each follow-up visit.
At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects with skin type Fitzpatrick IV and V
- •Women aged from 30 to 55 years with an understanding of all the information given by a written consent form
- •Working indoor office jobs (for minimum 8 hours)
排除标准
- •Personal or family history of skin cancer, especially melanoma
- •Consumption of any preparations containing glutathione within 1 month of enrollment
- •Use of any topical skin brightening or whitening preparations within 1 month of enrollment
- •Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas
- •A pregnant or breastfeeding mother
- •Personal history of drug allergy or skin disorder due to side effects of oral therapy
研究组 & 干预措施
Glutathione Group
Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.
干预措施: Glutathione (Drug)
Placebo Group
Subjects were randomised to receive Placebo capsules, which were identical in appearance and packaged in identical-looking containers with the Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Change from Baseline Spot UV at 4 weeks
时间窗: 4 weeks
Total reduction (improvement) of spot UV
Change from Baseline Spot UV at 8 weeks
时间窗: 8 weeks
Total reduction (improvement) of spot UV
Change from Baseline Spot Polarization at 4 weeks
时间窗: 4 weeks
Total reduction (improvement) of spot polarization
Change from Baseline Skin Tone at 12 weeks
时间窗: 12 weeks
Improvement of skin tone
Change from Baseline Spot Polarization at 8 weeks
时间窗: 8 weeks
Total reduction (improvement) of spot polarization
Change from Baseline Skin Tone at 4 weeks
时间窗: 4 weeks
Improvement of skin tone
Change from Baseline Skin Tone at 8 weeks
时间窗: 8 weeks
Improvement of skin tone
Change from Baseline Spot UV at 12 weeks
时间窗: 12 weeks
Total reduction (improvement) of spot UV
Change from Baseline Spot Polarization at 12 weeks
时间窗: 12 weeks
Total reduction (improvement) of spot polarization
次要结局
- Subjective Improvement at 4 weeks(4 weeks)
- Adverse events at 4 weeks(4 weeks)
- Subjective Improvement at 8 weeks(8 weeks)
- Adverse events at 8 weeks(8 weeks)
- Subjective Improvement at 12 weeks(12 weeks)
- Adverse events at 12 weeks(12 weeks)
研究者
Dr Irma Bernadette S Sitohang
Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) - Head of Cosmetic Dermatology Division of Dermatology and Venereology Department of Faculty of Medicine Universitas Indonesia / Cipto Mangunkusumo Hospital
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto