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

February 27, 2025 updated by: Tsong-Min Chang, Hungkuang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung City, Taiwan, 433304
        • Hungkuang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Centella asiatica extracellular vesicle formulation
Water-based formulation containing purified Centella asiatica extracellular vesicle as main active ingredient.
Other: Centella asiatica extracellular vesicle formulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
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.
Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
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.
Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
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.
Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
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.
Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
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.
Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hungkuang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Actual)

October 4, 2024

Study Completion (Actual)

October 16, 2024

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-064-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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