Clinical trial NCT06631859: The Safety and Efficacy Assessment of Cosmetic Products Containing Assam Tea Extracts in Volunteers.
Official title: The Effect of Cosmetic Products Containing Assam Tea (Camellia Sinensis Var. Assamica) Extracts on Irritation, Moisturization, Skin Elasticity, Wrinkles, and Satisfaction in Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Mae Fah Luang University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Skin hydration
timeFrame: 2 months
measure: Transepidermal water loss (TEWL)
timeFrame: 2 months
measure: Skin irritation
timeFrame: 2 months
measure: Values from Cutometer®
timeFrame: 2 months
measure: Values from Skin-Visiometer®
timeFrame: 2 months
measure: Sensory evaluation
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: School of Cosmetic Science, Mae Fah Luang University
state: Chiang Rai
Study officials:
References: