Healthy VolunteersNCT06631859
The Safety and Efficacy Assessment of Cosmetic Products Containing Assam Tea Extracts in Volunteers.
A study testing Cosmetic products containing 0% Assam tea and Cosmetic products containing 2.5% Assam tea in people with Healthy Volunteers, run by Mae Fah Luang University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cosmetic products containing 0% Assam tea and Cosmetic products containing 2.5% Assam tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 17 Mar 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
School of Cosmetic Science, Mae Fah Luang University
Mueang, Changwat Chiang Rai, 57100
About this study
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.
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
- Being tested
- Cosmetic products containing 0% Assam tea, Cosmetic products containing 2.5% Assam tea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic products containing 0% Assam teaOther
Cosmetic products containing 0% Assam tea
Cosmetic products containing 2.5% Assam teaOther
Cosmetic products containing 2.5% Assam tea
| Study group | Role | What they receive |
|---|---|---|
| Volunteers who recieved tested product | Experimental | Volunteers who recieved tested product Receives: Other: Cosmetic products containing 2.5% Assam tea |
| Volunteers who recieved base product | Placebo comparator | Volunteers who recieved base product Receives: Other: Cosmetic products containing 0% Assam tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin hydration
Measure skin hydration by using a Corneometer®
Measured: 2 months
Transepidermal water loss (TEWL)
Measure TEWL by using a Tewameter®
Measured: 2 months
Skin irritation
Evaluate redness and edema occurred after applying the tested products by closed patch test under occlusion with Finn chamber®
Measured: 2 months
Values from Cutometer®
Such as R0, R1, R2, R3, R4, R5, R6, R7, R8, R9
Measured: 2 months
Values from Skin-Visiometer®
Such as Volume, Surface, SEr, SEsc, SEsm, SEw
Measured: 2 months
Sensory evaluation
Measure the parameters such as color, odor, viscosity, texture, etc using labeled affective magnitude scale
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start17 Mar 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mae Fah Luang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631859
- Sponsor's protocol ID
- EC 23258-17
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06631859
- Acronym / sponsor ID
- EC 23258-17
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mae Fah Luang UniversityUniversity, hospital or other
- Study start
- 17 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteers who recieved tested product | Experimental | Other: Cosmetic products containing 2.5% Assam teaVolunteers who recieved tested product |
| Volunteers who recieved base product | Placebo comparator | Other: Cosmetic products containing 0% Assam teaVolunteers who recieved base product |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic products containing 0% Assam teaCosmetic products containing 0% Assam tea | Other | Volunteers who recieved base product |
| Cosmetic products containing 2.5% Assam teaCosmetic products containing 2.5% Assam tea | Other | Volunteers who recieved tested product |
Primary outcome
Skin hydration
Time frame: 2 months
Measure skin hydration by using a Corneometer®
Transepidermal water loss (TEWL)
Time frame: 2 months
Measure TEWL by using a Tewameter®
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®
Values from Cutometer®
Time frame: 2 months
Such as R0, R1, R2, R3, R4, R5, R6, R7, R8, R9
Values from Skin-Visiometer®
Time frame: 2 months
Such as Volume, Surface, SEr, SEsc, SEsm, SEw
Sensory evaluation
Time frame: 2 months
Measure the parameters such as color, odor, viscosity, texture, etc using labeled affective magnitude scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic products containing 0% Assam tea and Cosmetic products containing 2.5% Assam tea in people with Healthy Volunteers, run by Mae Fah Luang University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin hydration (time frame: 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.