Clinical Efficacy and Safety of MB LuxuryⓇ Product Containing Epigallocathecin Gallate (EGCG) on Erythema, Melanin, and Skin Hydration

Overview

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: 1. Does MB Luxury significantly reduce melanin index after 84 days of use? 2. Does MB Luxury significantly reduce erythema index after 84 days of use? 3. Does MB Luxury significantly improve skin moisture after 84 days of use? 4. How do the changes in the intervention group compare to the control group? MB Luxury is not available through an expanded access program.

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. Study Locations: The study was conducted at \[masukkan lokasi penelitian Anda, misal: Klinik Kecantikan X / Laboratorium Penelitian Y, Kota, Provinsi\]. All measurements were performed in a controlled environment (temperature 22-24°C, relative humidity 40-60%) to minimize environmental variation. Instruments: * Mexameter® MX 18 (Courage + Khazaka, Germany): Measures melanin index (absorption at 660 nm) and erythema index (absorption at 568 nm). * Corneometer® CM 825 (Courage + Khazaka, Germany): Measures skin moisture based on electrical capacitance of the stratum corneum. Ethical Approval: This study was conducted in accordance with the Declaration of Helsinki (2013) and Good Clinical Practice (GCP) guidelines. Ethical approval was obtained from the Ethics Committee of Universitas Islam Sultan Agung (Ethics Approval Number: \[Masukkan Nomor Persetujuan Etik Anda\]). All respondents provided written informed consent prior to participation. Statistical Analysis: Data were analyzed using SPSS. The Shapiro-Wilk test was used to assess normality. Since data were not normally distributed (p \< 0.05), the Mann-Whitney test was used to compare pre- and post-intervention values within each group (Day 0 vs. Day 84) and to compare the change scores (Δ) between the intervention and control groups. A p-value \< 0.05 was considered statistically significant.