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Clinical Trials/NCT06850935
NCT06850935CompletedNot Applicable

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

Hungkuang University2 sites20 target enrollmentStarted: September 4, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Change in skin melanin content

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tsong-Min Chang

Vice President

Hungkuang University

Study Sites (2)

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