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Completed
NCT07725900
Clinical Efficacy and Safety of MB LuxuryⓇ Product Containing Epigallocathecin Gallate (EGCG) on Erythema, Melanin, and Skin Hydration
Conditions: Hyperpigmentation, Dry Skin, Erythema
Sex: All
Ages: 17 Years – 40 Years
Healthy volunteers: Yes
Phase: PHASE2, PHASE3
Enrollment: 300
Sponsor: Naniek Widyaningrum
Location: Universitas Islam Sultan Agung Semarang Central Java
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07725900). StuddyBuddy aggregates publicly available trial information.