A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of liposomal glutathione (LipogloTM) and non-liposomal oral glutathione formulations on skin pigmentation and barrier function in healthy adults.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in skin pigmentation measured by facial melanin level using Mexameter
研究概览
简要总结
| Skin pigmentation concerns and compromised skin barrier function are common skin-related and quality-of-life issues among adults. Oxidative stress plays an important role in skin ageing and pigmentation changes. Oral glutathione supplementation is widely used for improving skin colour and skin health; however, conventional glutathione formulations may have limited bioavailability. |
Liposomal glutathione (LipogloTM) is a novel formulation designed to improve oral absorption and systemic availability of glutathione. This randomised, double-blind, parallel-group, placebo-controlled study aims to evaluate the efficacy and safety of liposomal glutathione compared with non-liposomal glutathione and placebo in healthy adults.
The study will assess changes in skin pigmentation, skin colour, skin hydration, skin barrier function, and overall skin appearance. Safety will be evaluated through laboratory assessments and monitoring of adverse events. The study is intended to generate clinical evidence supporting the effectiveness and safety of oral glutathione formulations for improving skin pigmentation and skin health in healthy adults.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- Healthy individuals who are able to understand all the information provided and who give written informed consent.
- The study will include healthy participants aged between 20 and 50 years.
- Eligible subjects will have skin types IV or V according to the Fitzpatrick scale.
- Participants engaged in indoor office-based occupations for at least 8 hours per day 5.
- Subject with facial melanin index ranging between 200 and 350 will be included in the study.
- Non-smoker participants included in the study 7.
- All participants will be confirmed to be in good health based on medical history, physical examination, and clinical laboratory evaluations, including serological, haematological, and biochemical assessments.
排除标准
- History of skin cancer in the participant or close family members, particularly melanoma.
- Use of oral glutathione supplements within one month before study enrolment 3.
- Use of topical skin-brightening or whitening products within one month before enrolment 4.
- Presence of skin conditions or pigmentation disorders that may affect study assessments 5.
- Pregnant or breastfeeding women 6.
- History of allergy or hypersensitivity to oral medications 7.
- Presence of any major medical illness that may interfere with study participation 8.
- Abnormal liver function test results.
结局指标
主要结局
Change in skin pigmentation measured by facial melanin level using Mexameter
时间窗: Baseline, week 2, week 4, week 8 and week 12.
次要结局
- To assess the change in skin colour parameters, including pigmentation and erythema using a Mexameter.(Baseline, week 2, week 4, week 8 and week 12.)
- To assess changes in facial skin texture and appearance, including UV spots, pore characteristics, skin evenness, wrinkles, smoothness, and scaliness, using blinded dermatologist evaluation using subjective assessment and standardized facial photography along with ImageJ analysis.(Baseline, week 2, week 4, week 8 and week 12.)
- To evaluate changes in skin barrier function measure using TEWL via Tewameter.(Baseline, week 2, week 4, week 8 and week 12.)
- To assess changes in skin hydration using the Corneometer(Baseline, week 2, week 4, week 8 and week 12.)
- To assess skin firmness and elasticity using the Cutometer(Baseline, week 2, week 4, week 8 and week 12.)
- To assess subjective changes in skin properties, as reported by participants using a 4-point rating scale.(Baseline, week 2, week 4, week 8 and week 12.)
- To evaluate changes in systemic glutathione status, including plasma reduced glutathione(GSH) and oxidized/protein-bound glutathione (GSSG and GSSP) levels, measured using a validated LC-MS method.(Baseline and week 12)
研究者
Dr Vishal Chakkarwar
InventaLife Research Solutions Pvt. Ltd.
研究点 (1)
标识符
- CTRI 编号
- CTRI/2026/03/107035
日期
- 最近更新
- (6个月前)