Clinical trial NCT06850935: Evaluation of Effects on Skin Quality of a Centella Asiatica Extracellular Vesicle-based Skin Care Formulation.
Official title: Evaluation of the Skin Care Effects of Kristen Claire Supreme Rejuvenation Essence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hungkuang University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in skin hydration
timeFrame: Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
measure: Change in skin melanin content
timeFrame: Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
measure: Change in skin elasticity
timeFrame: Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
measure: Change in skin wrinkle percentage
timeFrame: Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
measure: Change in skin redness percentage
timeFrame: Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
measure: Change in skin pore percentage
timeFrame: Assessment conducted every 7 days including Day 0 from Day 0 to Day 28 after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Hungkuang University
Study officials:
References: