HyperpigmentationPhase 2/3NCT07725900
Clinical Efficacy and Safety of MB LuxuryⓇ Product Containing Epigallocathecin Gallate (EGCG) on Erythema, Melanin, and Skin Hydration
A Phase 2/3 study testing MB Luxury Skincare containing Epigallocatechin Gallate (EGCG) in people with Hyperpigmentation and Dry Skin, run by Naniek Widyaningrum at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation, Dry Skin, Erythema
- What is being tested?
- MB Luxury Skincare containing Epigallocatechin Gallate (EGCG)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2025to 1 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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?
MB Luxury is not available through an expanded access program.
Read the 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.
- Conditions
- Hyperpigmentation, Dry Skin, Erythema
- Being tested
- MB Luxury Skincare containing Epigallocatechin Gallate (EGCG)
- Keywords
- EGCG, Epigallocatechin Gallate, Melanin, Erythema
- Medical subject headings
- Hyperpigmentation, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MB Luxury Skincare containing Epigallocatechin Gallate (EGCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Dec 2025
- Primary completion1 Mar 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naniek Widyaningrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naniek Widyaningrum, Universitas Islam Sultan Agung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725900
- Sponsor's protocol ID
- No.631/XI/2025/Komisi Bioetik
- Other IDs
- No. 171/SPKC/C.C4/PPK.DHK/IV/2
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07725900
- Acronym / sponsor ID
- No.631/XI/2025/Komisi Bioetik
- Conditions
- Hyperpigmentation, Dry Skin, Erythema
- Keywords
- EGCG, Epigallocatechin Gallate, Melanin, Erythema
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Naniek WidyaningrumUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
MB Luxury is not available through an expanded access program.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB Luxury Skincare with EGCG | Experimental | Other: MB Luxury Skincare containing Epigallocatechin Gallate (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. |
| Control Group | Placebo comparator | 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Control Group, MB Luxury Skincare with EGCG |
Primary outcome
Change in Melanin Index from Baseline to Day 84
Time frame: Baseline (Day 0) and 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).
Change in Erythema Index from Baseline to Day 84
Time frame: Baseline (Day 0) and 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.
Change in Skin Moisture Index from Baseline to Day 84
Time frame: Baseline (Day 0) and 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MB Luxury Skincare containing Epigallocatechin Gallate (EGCG) in people with Hyperpigmentation and Dry Skin, run by Naniek Widyaningrum at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Melanin Index from Baseline to Day 84 (time frame: Baseline (Day 0) and Day 84). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.