The Safety and Efficacy Assessment of Cosmetic Products Containing Assam Tea Extracts in Volunteers.

NCT ID: NCT06631859

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-17

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Volunteers who recieved tested product

Volunteers who recieved tested product

Group Type EXPERIMENTAL

Cosmetic products containing 2.5% Assam tea

Intervention Type OTHER

Cosmetic products containing 2.5% Assam tea

Volunteers who recieved base product

Volunteers who recieved base product

Group Type PLACEBO_COMPARATOR

Cosmetic products containing 0% Assam tea

Intervention Type OTHER

Cosmetic products containing 0% Assam tea

Interventions

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Cosmetic products containing 0% Assam tea

Cosmetic products containing 0% Assam tea

Intervention Type OTHER

Cosmetic products containing 2.5% Assam tea

Cosmetic products containing 2.5% Assam tea

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mae Fah Luang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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School of Cosmetic Science, Mae Fah Luang University

Mueang, Changwat Chiang Rai, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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EC 23258-17

Identifier Type: -

Identifier Source: org_study_id

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