Clinical Efficacy and Safety of MB LuxuryⓇ Product Containing Epigallocathecin Gallate (EGCG) on Erythema, Melanin, and Skin Hydration: A Large-Scale Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Melanin Index from Baseline to Day 84
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of MB Luxury skincare containing the active ingredient Epigallocatechin Gallate (EGCG) from green tea (Camellia sinensis L.) on skin melanin index, erythema index, and skin moisture levels over 84 days of use.
This is a quasi-experimental study with a nonequivalent control group pretest-posttest design. A total of 300 respondents were assigned to the intervention group (using MB Luxury twice daily for 84 days) and 50 respondents were assigned to the control group (receiving no product during the same period).
Study details include:
- Study Duration: 84 days (12 weeks)
- Treatment Duration: 84 days
- Visit Frequency: Measurements were taken at baseline (Day 0) and at weekly intervals (Day 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, and 84) for the intervention group. For the control group, measurements were taken at baseline and Day 84.
- Health Measurements: Melanin and erythema indices were measured using Mexameter® MX 18, and skin moisture was measured using Corneometer® CM 825.
The study aims to answer the following research questions:
- Does MB Luxury significantly reduce melanin index after 84 days of use?
- Does MB Luxury significantly reduce erythema index after 84 days of use?
- Does MB Luxury significantly improve skin moisture after 84 days of use?
- How do the changes in the intervention group compare to the control group?
MB Luxury is not available through an expanded access program.
详细描述
This study was conducted to evaluate the clinical efficacy and safety of MB Luxury skincare, a topical formulation containing Epigallocatechin Gallate (EGCG) as the active pharmaceutical ingredient. EGCG is the predominant polyphenol in green tea (Camellia sinensis L.) and has been extensively studied for its antioxidant, anti-inflammatory, anti-melanogenesis, and skin hydration properties.
Study Design:
This is a quasi-experimental study with a nonequivalent control group pretest-posttest design. A total of 350 respondents were recruited using consecutive sampling. The intervention group (n=300) applied MB Luxury twice daily (morning and evening) on the face for 84 consecutive days. The control group (n=50) received no product during the same period.
Study Population:
- Inclusion criteria: Healthy adults aged 17-45 years, willing to use the product regularly for 84 days, and willing to sign informed consent.
- Exclusion criteria: Pregnant or lactating women, active dermatosis (severe atopic dermatitis, psoriasis, active acne grade ≥3), history of keloid or hypertrophic scar, use of other topical depigmenting agents, retinoids, or corticosteroids within 2 weeks prior to the study, and cosmetic procedures (laser, chemical peeling, microdermabrasion) within 4 weeks prior to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to use MB LuxuryⓇ products alone for 84 days
- •Willing to fill out an informed consent
- •Aged 20-40 years
- •Not currently experiencing skin irritation
- •Not having a history of allergies to MB LuxuryⓇ product components
排除标准
- •Individuals under 20 years of age and over 40 years of age
- •Currently experiencing skin irritation or disorders
- •Have a history of allergies to MB LuxuryⓇ product components.
研究组 & 干预措施
MB Luxury Skincare with EGCG
Participants in this arm applied MB Luxury skincare containing Epigallocatechin Gallate (EGCG) 0.4% w/w twice daily (morning and evening) on the face for 84 consecutive days. The product was applied after cleansing the face, with a pea-sized amount (approximately 0.5 grams) per application. Measurements of melanin index, erythema index, and skin moisture were taken at baseline (Day 0) and at weekly intervals (Day 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, and 84) using Mexameter® MX 18 and Corneometer® CM 825.
干预措施: MB Luxury Skincare containing Epigallocatechin Gallate (EGCG) (Other)
Control Group
Participants in this arm receive placebo during the 84-day study period. They were instructed to maintain their usual daily skincare routine but to avoid using any new skincare products or treatments during the study. Measurements of melanin index, erythema index, and skin moisture were taken at baseline (Day 0) and at Day 84 using Mexameter® MX 18 and Corneometer® CM 825 to assess natural changes in skin parameters over the study period.
干预措施: MB Luxury Skincare containing Epigallocatechin Gallate (EGCG) (Other)
结局指标
主要结局
Change in Melanin Index from Baseline to Day 84
时间窗: Baseline (Day 0) and Day 84
Change in melanin index measured using Mexameter® MX 18 on the face (average of 3 measurement points: left cheek, right cheek, and forehead). Melanin index is measured by skin light absorption at 660 nm, with values ranging from 0 to 999. Higher values indicate higher melanin content (darker skin).
Change in Erythema Index from Baseline to Day 84
时间窗: Baseline (Day 0) and Day 84
Change in erythema index measured using Mexameter® MX 18 on the face (average of 3 measurement points: left cheek, right cheek, and forehead). Erythema index is measured by skin light absorption at 568 nm, with values ranging from 0 to 999. Higher values indicate greater redness/inflammation.
Change in Skin Moisture Index from Baseline to Day 84
时间窗: Baseline (Day 0) and Day 84
Change in skin moisture measured using Corneometer® CM 825 on the face (average of 3 measurement points: left cheek, right cheek, and forehead). Skin moisture is measured by electrical capacitance of the stratum corneum, with values ranging from 0 to 120. Higher values indicate better skin hydration.
次要结局
未报告次要终点
研究者
Naniek Widyaningrum
Dr
Universitas Islam Sultan Agung