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

NCT06850935 | Completed

• 1 other identifier: 24-064-A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Quality; Skin Wrinkles; Melanin Hyperpigmentation; Skin Hydration; Skin Elasticity; Skin Redness

Keywords

Centella asiatica; Extracellular vesicles; Antioxidants; Cosmetics; Skin care; Anti-inflammatory; Skin whitening; UV damage; Photoaging; skin quality; gotu kola

Outcome Measures

Primary Outcomes (6)

• Change in skin hydration

  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

  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

  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

  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

  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

  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

Study Arms (1)

Centella asiatica extracellular vesicle formulation

EXPERIMENTAL

Water-based formulation containing purified Centella asiatica extracellular vesicle as main active ingredient.

Other: Centella asiatica extracellular vesicle formulation

Interventions

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.

Centella asiatica extracellular vesicle formulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Currently using any medications or other skincare products

Sponsors & Collaborators

• Hungkuang University: lead

Study Sites (1)

Hungkuang University

Taichung, 433304, Taiwan

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: February 28, 2025
• Study Start: September 4, 2024
• Primary Completion: October 4, 2024
• Study Completion: October 16, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

TW (1)