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

NCT06631859 | Completed

• 1 other identifier: EC 23258-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Skin hydration

  Measure skin hydration by using a Corneometer®

  2 months

• Transepidermal water loss (TEWL)

  Measure TEWL by using a Tewameter®

  2 months

• Skin irritation

  Evaluate redness and edema occurred after applying the tested products by closed patch test under occlusion with Finn chamber®

  2 months

• Values from Cutometer®

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

  2 months

• Values from Skin-Visiometer®

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

  2 months

• Sensory evaluation

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

  2 months

Study Arms (2)

Volunteers who recieved tested product

EXPERIMENTAL

Volunteers who recieved tested product

Other: Cosmetic products containing 2.5% Assam tea

Volunteers who recieved base product

PLACEBO COMPARATOR

Volunteers who recieved base product

Other: Cosmetic products containing 0% Assam tea

Interventions

Cosmetic products containing 0% Assam tea OTHER

Cosmetic products containing 0% Assam tea

Volunteers who recieved base product

Cosmetic products containing 2.5% Assam tea OTHER

Cosmetic products containing 2.5% Assam tea

Volunteers who recieved tested product

Eligibility Criteria

• Age: 35 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mae Fah Luang University: lead

Study Sites (1)

School of Cosmetic Science, Mae Fah Luang University

Mueang, Changwat Chiang Rai, 57100, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: March 17, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

TH (1)