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Completed

NCT Number: NCT06850935

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

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.

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Key information

Conditions

Skin Quality Erythema Melanin Hyperpigmentation Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Elasticity Skin Hydration Skin Manifestations Skin Redness Skin Wrinkles Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hungkuang University

Taichung, 433304, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Centella asiatica extracellular vesicle formulation

Other

Water-based formulation containing purified Centella asiatica extracellular vesicle as main active ingredient. Applied twice daily at two drops per use to the face after face cleansing for 28 consecutive days.

Primary outcomes

  1. Change in skin hydration

    Time frame: 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.

  2. Change in skin melanin content

    Time frame: 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.

  3. Change in skin elasticity

    Time frame: 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.

  4. Change in skin wrinkle percentage

    Time frame: 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.

  5. Change in skin redness percentage

    Time frame: 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.

  6. Change in skin pore percentage

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hungkuang University

Other

Registry information

Official study title

Evaluation of the Skin Care Effects of Kristen Claire Supreme Rejuvenation Essence

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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