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Completed

NCT Number: NCT06631859

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

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Key information

Conditions

Healthy Volunteers

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Cosmetic Science, Mae Fah Luang University

Mueang, Changwat Chiang Rai, 57100, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cosmetic products containing 0% Assam tea

Other

Cosmetic products containing 0% Assam tea

Cosmetic products containing 2.5% Assam tea

Other

Cosmetic products containing 2.5% Assam tea

Primary outcomes

  1. Skin hydration

    Time frame: 2 months

    Measure skin hydration by using a Corneometer®

  2. Transepidermal water loss (TEWL)

    Time frame: 2 months

    Measure TEWL by using a Tewameter®

  3. 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®

  4. Values from Cutometer®

    Time frame: 2 months

    Such as R0, R1, R2, R3, R4, R5, R6, R7, R8, R9

  5. Values from Skin-Visiometer®

    Time frame: 2 months

    Such as Volume, Surface, SEr, SEsc, SEsm, SEw

  6. Sensory evaluation

    Time frame: 2 months

    Measure the parameters such as color, odor, viscosity, texture, etc using labeled affective magnitude scale

Sponsors and collaborators

Lead sponsor

Mae Fah Luang University

Other

Registry information

Official study title

The Effect of Cosmetic Products Containing Assam Tea (Camellia Sinensis Var. Assamica) Extracts on Irritation, Moisturization, Skin Elasticity, Wrinkles, and Satisfaction in Volunteers.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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