Evaluation of Effects on Skin Quality of a Centella Asiatica Extracellular Vesicle-based Skin Care Formulation.

Not Applicable

Completed

• Conditions: Skin Elasticity; Skin Quality; Skin Wrinkles; Skin Redness; Melanin Hyperpigmentation; Skin Hydration

• Registration Number: NCT06850935
• Lead Sponsor: Hungkuang University

Brief Summary

The study evaluates the effects of a skin care formulation containing Centella asiatica extracellular vesicles as the main active ingredient on facial appearance and skin quality in healthy participants.

Detailed Description

Twenty healthy participants will be enrolled and will first undergo a 24-hour skin patch test on the forearm to assess potential irritation or allergic reactions to the test product. After screening, participants were asked to use the test product twice daily (morning and evening) after cleansing their face without using exfoliating products for 28 consecutive days. Each application involved 2 drops, evenly applied to the face using fingertips for absorption. Product usage was self-recorded, and the products were stored at room temperature.

The skin quality tests were conducted at the investigation site Hungkuang University onsite by the principal investigator. Each participant was to allocate 1 hour per test (including cleansing and waiting time). Skin quality tests were performed as a baseline test on day 0 (before using the test product), and subsequent tests at 7, 14, 21, and 28 days after test product use.

Measured parameters during assessment will include skin hydration, melanin content, skin elasticity, wrinkle percentage, redness area percentage, and pore percentage.

Study Timeline

• Study Start: 2024-09-04
• Primary Completion: 2024-10-04
• Study Completion: 2024-10-16
• Status Verified: 2025-02
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy adults of any gender from the age of 18 to 60 years (inclusive).
• Absence of chronic diseases, major illnesses, or allergies.

Exclusion Criteria

• Currently using any medications or other skincare products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in skin melanin content	Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment	To measure skin melanin content from Day 0 Day 28 of the study using C+K Multi Probe Adaptor MPA580 system with Mexameter MX18 probe, which measures melanin and hemoglobin content using RGB light absorption at wavelengths 568 nm, 660 nm, and 880 nm. Data will be expressed as percentage of change in skin melanin content relative to Day 0.
Change in skin elasticity	Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment	To measure skin elasticity from Day 0 Day 28 of the study using C+K Multi Probe Adaptor MPA580 system with Cutometer Dual MPA580 probe by measuring skin stretching properties using suction-based method. Data will be expressed as percentage of change in skin elasticity relative to Day 0.
Change in skin wrinkle percentage	Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment	To measure skin elasticity from Day 0 Day 28 of the study using VISIA Skin Analysis System by using standard white light to detect shadow variations to determine the distribution and number of wrinkles. Fewer wrinkles yield higher percentages. Data will be expressed as percentage of change in skin wrinkle percentage relative to Day 0.
Change in skin hydration	Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment	To measure skin hydration from Day 0 Day 28 of the study using C+K Multi Probe Adaptor MPA580 system with Corneometer CM825 Data probe, which evaluates the dielectric constant related to epidermal moisture at a depth of 60-100 µm. Data will be expressed as percentage of change in skin hydration relative to Day 0.
Change in skin redness percentage	Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment	To measure skin elasticity from Day 0 Day 28 of the study using VISIA Skin Analysis System by using RBX polarized light to identify vascular or inflammatory issues. Smaller red zones result in higher percentages. Data will be expressed as percentage of change in skin redness percentage relative to Day 0.
Change in skin pore percentage	Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment	To measure skin elasticity from Day 0 Day 28 of the study using VISIA Skin Analysis System by using white light to analyze shadowed pore depressions and darker areas relative to surrounding skin. Fewer pores yield higher percentages. Data will be expressed as percentage of change in skin pore percentage relative to Day 0.

Trial Locations

Locations (1)

Hungkuang University; 🇨🇳 Taichung City, Taiwan