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

Clinical Efficacy and Safety of MB LuxuryⓇ Product Containing Epigallocathecin Gallate (EGCG) on Erythema, Melanin, and Skin Hydration: A Large-Scale Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Erythema; Hyperpigmentation; Dry Skin
• Intervention / Treatment: Other: MB Luxury Skincare containing Epigallocatechin Gallate (EGCG)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Semarang, Central Java, Indonesia
      • Universitas Islam Sultan Agung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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, and not having a history of allergies to MB LuxuryⓇ product components

Exclusion Criteria:

• Individuals under 20 years of age and over 40 years of age, currently experiencing skin irritation or disorders, and have a history of allergies to MB LuxuryⓇ product components.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: MB Luxury Skincare containing Epigallocatechin Gallate (EGCG); MB Luxury is a topical skincare product formulated with Epigallocatechin Gallate (EGCG) 0.4% w/w as the active ingredient, derived from green tea (Camellia sinensis L.). The product is presented as a white to off-white cream in a 30 mL airless pump bottle. Participants in the intervention group applied a pea-sized amount (approximately 0.5 grams) of the product twice daily (morning and evening) to the entire face, avoiding the eye area and lips, after cleansing the face. The product was used for 84 consecutive days. The formulation also contains emollients and humectants including glycerin, hyaluronic acid, and ceramides to support skin hydration. No other active skincare products (e.g., depigmenting agents, retinoids, corticosteroids) were permitted during the study period.
Placebo Comparator: 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.	Other: MB Luxury Skincare containing Epigallocatechin Gallate (EGCG); MB Luxury is a topical skincare product formulated with Epigallocatechin Gallate (EGCG) 0.4% w/w as the active ingredient, derived from green tea (Camellia sinensis L.). The product is presented as a white to off-white cream in a 30 mL airless pump bottle. Participants in the intervention group applied a pea-sized amount (approximately 0.5 grams) of the product twice daily (morning and evening) to the entire face, avoiding the eye area and lips, after cleansing the face. The product was used for 84 consecutive days. The formulation also contains emollients and humectants including glycerin, hyaluronic acid, and ceramides to support skin hydration. No other active skincare products (e.g., depigmenting agents, retinoids, corticosteroids) were permitted during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Melanin Index from Baseline to 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).	Baseline (Day 0) and Day 84
Change in Erythema Index from Baseline to 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.	Baseline (Day 0) and Day 84
Change in Skin Moisture Index from Baseline to 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.	Baseline (Day 0) and Day 84

Collaborators and Investigators

• Sponsor: Naniek Widyaningrum

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): June 1, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Erythema; EGCG; Epigallocatechin Gallate; Melanin
• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases; Pigmentation Disorders; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Erythema; Hyperpigmentation
• Other Study ID Numbers: No.631/XI/2025/Komisi Bioetik; No. 171/SPKC/C.C4/PPK.DHK/IV/2 (Other Grant/Funding Number: Ministry of Higher Education, Science, and Technology of the Republic of Indonesia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No