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COMPLETED
NCT07725900
PHASE2/PHASE3

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

Sponsor: Naniek Widyaningrum

View on ClinicalTrials.gov

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: 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.

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

Key Details

Gender

All

Age Range

17 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-12-01

Completion Date

2026-06-01

Last Updated

2026-07-24

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Universitas Islam Sultan Agung

Semarang, Central Java, Indonesia