The Safety and Efficacy Assessment of Cosmetic Products Containing Assam Tea Extracts in Volunteers.
The Effect of Cosmetic Products Containing Assam Tea (Camellia Sinensis Var. Assamica) Extracts on Irritation, Moisturization, Skin Elasticity, Wrinkles, and Satisfaction in Volunteers.
Thailand has entered an aging society, prompting increased research on improving the elderly quality of life and preventing age-related diseases, with a particular focus on skin aging. Skin aging is linked to the degradation of dermal and epidermal tissue, leading to decreased collagen, elastin, and glycosaminoglycans, which causes reduced skin elasticity and wrinkles.
Assam tea is native to northern Thailand and is traditionally used in local products like fermented "Miang." Research shows that Assam tea contains high levels of polyphenols, particularly catechins, which have strong antioxidant properties that help combat conditions such as cancer, cardiovascular disease, and skin aging.
The study aims to study the effect of cosmetic products from Assam tea on irritation, moisturization, skin elasticity, wrinkles, and satisfaction in volunteers to enhance its value, particularly for the elderly. This effort is intended to boost the local economy, promote community-based tourism, and expand Assam tea products to national and international markets, ultimately improving livelihoods and addressing environmental concerns in northern Thailand.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Chiang Rai
-
Mueang, Chiang Rai, Thailand, 57100
- School of Cosmetic Science, Mae Fah Luang University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 35 years and older
- Good physical and mental health
- Willing and able to provide informed consent to participate and complete the entire duration of the study
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Presence of existing dermatological conditions
- History of autoimmune disorders
- Prior use of products related to wrinkle reduction or those containing active ingredients that stimulate collagen or elastin production, including topical and oral products used within the past three months (e.g., coenzyme Q10, marine extracts, pine bark extract, glutathione, and vitamin C)
- Participation in any other volunteer study or program within the past three months
- Use of the following medications within the past three months: contraceptives, phenytoin, hydantoin, levodopa, chloroquine, cancer chemotherapy drugs, or medications containing heavy metals
- History of receiving dermatological or cosmetic procedures such as IPL (Intense Pulse Light) laser, phonophoresis, iontophoresis, laser treatments, Botox injections, fillers, or stem cell injections
- Volunteers who exhibit sensitivity or irritation to the test products used in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Volunteers who recieved tested product
|
Cosmetic products containing 2.5% Assam tea
|
|
Placebo Comparator: Volunteers who recieved base product
|
Cosmetic products containing 0% Assam tea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin hydration
Time Frame: 2 months
|
Measure skin hydration by using a Corneometer®
|
2 months
|
|
Transepidermal water loss (TEWL)
Time Frame: 2 months
|
Measure TEWL by using a Tewameter®
|
2 months
|
|
Skin irritation
Time Frame: 2 months
|
Evaluate redness and edema occurred after applying the tested products by closed patch test under occlusion with Finn chamber®
|
2 months
|
|
Values from Cutometer®
Time Frame: 2 months
|
Such as R0, R1, R2, R3, R4, R5, R6, R7, R8, R9
|
2 months
|
|
Values from Skin-Visiometer®
Time Frame: 2 months
|
Such as Volume, Surface, SEr, SEsc, SEsm, SEw
|
2 months
|
|
Sensory evaluation
Time Frame: 2 months
|
Measure the parameters such as color, odor, viscosity, texture, etc using labeled affective magnitude scale
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EC 23258-17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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