A Phase 2/3 interventional study of MB Luxury Skincare containing Epigallocatechin Gallate (EGCG) in Hyperpigmentation, Dry Skin and Erythema, sponsored by Naniek Widyaningrum. Completed at 1 site in Indonesia. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Naniek Widyaningrum · Phase 2/3, Interventional, and Treatment
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:
The study aims to answer the following research questions:
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:
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:
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.
127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.
This study's enrollment of 300 is above the median of 32 across 113 interventional studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →This is the only study on the registry with Naniek Widyaningrum as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 0) and Day 84
Plan to share: No
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Ran from Dec 2025 to primary completion in Mar 2026, 3 months.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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