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

NCT07725900 | Completed Phase 2

• 2 other identifiers: No.631/XI/2025/Komisi BioetikNo. 171/SPKC/C.C4/PPK.DHK/IV/2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Hyperpigmentation; Dry Skin; Erythema

Keywords

EGCG; Epigallocatechin Gallate; Melanin; Erythema

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

MB Luxury Skincare with EGCG

EXPERIMENTAL

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)

Control Group

PLACEBO COMPARATOR

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)

Interventions

MB Luxury Skincare containing Epigallocatechin Gallate (EGCG) OTHER

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.

Control Group; MB Luxury Skincare with EGCG

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Naniek Widyaningrum: lead

Study Sites (1)

Universitas Islam Sultan Agung

Semarang, Central Java, Indonesia

Location

MeSH Terms

Conditions

Hyperpigmentation; Erythema

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)