Collagen Synthesis, Skin Condition
Conditions
Keywords
MAXI Collagen, Hydrolyzed collagen, Oral Collagen
Brief summary
The objective of this study is to evaluate the effect of oral collagen drink and MAXI collagen drink on human skin condition improvement.
Detailed description
This study is a single-center, double-blinded, parallel human trial designed to evaluate the skin beauty effect of oral collagen drink and MAXI collagen drink. Healthy adult participants aged 18-60 years will be enrolled. Participants will be informed to consume test samples daily for 4 consecutive weeks. Skin measurement and self-assessment questionnaires will be conducted at baseline (before intake), after 1 week, and 4 weeks of consumption.
Interventions
DIETARY_SUPPLEMENTCollagen Drink
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 5 g Collagen Powder
DIETARY_SUPPLEMENTMAXI Collagen Drink
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 15 mL MAXI Collagen Liquid (equivalent to 5 g of deep hydrolyzed collagen net weight)
DIETARY_SUPPLEMENTMAXI Collagen Drink_High dose
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 30 mL MAXI Collagen Liquid (equivalent to 10 g of deep hydrolyzed collagen net weight)
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Chinese subjects aged 18 to 60 years, both male and female. * Wrinkle Severity: Crow's feet graded 2-4; under-eye fine lines graded 2-5; nasolabial folds graded 1-3. * Presence of facial skin laxity and sagging. * Ability to undergo skin examinations and pre-treatment in the designated test areas. * Ability to understand the trial process, participate voluntarily, and sign a written Informed Consent Form (ICF).
Exclusion criteria
* Pregnant or lactating women, or those planning to become pregnant in the near future. * Highly sensitive constitution, history of allergic diseases, or history of allergies to cosmetics. * Presence of skin diseases (e.g., psoriasis, eczema, atopic dermatitis, severe acne) or other chronic systemic diseases. * Skin conditions in the test area such as birthmarks, hyperpigmentation, inflammation, scars, nevi (moles), or hypertrichosis (excessive hair). * Use of anti-inflammatory drugs (e.g., oral or topical corticosteroids) within the past month. * Use of cosmetics or other products with similar efficacy within the past 2 weeks. * Participation in other human clinical trials for cosmetics within the past month. * Any other conditions deemed unsuitable for participation based on clinical assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of collagen fiber fluorescence intensity | Change from Baseline collagen intensity at 4 weeks | SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to evaluate the density and quality of dermal collagen fibers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of skin elasticity | Change from Baseline skin elasticity at 4 weeks | Cutometer® MPA580 (CK, Germany) was utilized to measure the gross elasticity of the skin using suction method. |
| The change of skin firmness | Change from Baseline skin firmness at 4 weeks | Cutometer® MPA580 (CK, Germany) was utilized to measure skin firmness and the area under the suction curve. |
| The change of epidermal thickness | Change from Baseline epidermal thickness at 4 weeks | SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to measure the depth of the epidermal layer using optical imaging. |
| The change of cheek skin roughness | Change from Baseline skin roughness at 4 weeks | AEVA-HE (EOTECH, France) was utilized to measure the arithmetic average roughness (Ra value) of the cheek surface. |
| The change of the Dermal-Epidermal Junction (DEJ) structures | Change from Baseline DEJ status at 4 weeks | SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to assess the structural integrity and epithelial-connective tissue interface (ECTI) of the DEJ. |
| The change of nasolabial folds volume | Change from Baseline wrinkle parameters at 4 weeks | AEVA-HE (EOTECH, France) was utilized to quantify the 3D morphological changes of the nasolabial folds volume. |
| The change of nasolabial folds depth | Change from Baseline wrinkle parameters at 4 weeks | AEVA-HE (EOTECH, France) was utilized to quantify the 3D morphological changes of the nasolabial folds depth. |
| The change of crow's feet volume | Change from Baseline crow's feet parameters at 4 weeks | AEVA-HE (EOTECH, France) was utilized to measure the severity of crow's feet volume. |
| The change of crow's feet depth | Change from Baseline crow's feet parameters at 4 weeks | AEVA-HE (EOTECH, France) was utilized to measure the severity of crow's feet depth. |
| The change of the volume of fine lines under the eyes | Change from Baseline fine lines at 4 weeks | AEVA-HE (EOTECH, France) was utilized to assess the volume of fine lines under the eyes. |
| The change of the mean depth of fine lines under the eyes | Change from Baseline fine lines at 4 weeks | AEVA-HE (EOTECH, France) was utilized to assess the mean depth of fine lines under the eyes. |
| The change of cheek (malar) volume | Change from Baseline cheek volume at 4 weeks | AEVA-HE (EOTECH, France) was utilized to measure the 3D volume of the cheek area for lifting effects. |
| The change of jawline length | Change from Baseline jawline parameters at 4 weeks | AEVA-HE (EOTECH, France) was utilized to measure the linear length and contour of the jawline. |
| The change of skin pores counts | Change from Baseline pore parameters at 4 weeks | AEVA-HE (EOTECH, France) was utilized to perform 3D imaging and quantification of skin pores counts. |
| The change of skin pores volume | Change from Baseline pore parameters at 4 weeks | AEVA-HE (EOTECH, France) was utilized to perform 3D imaging and quantification of skin pores volume. |
| The change of skin hydration | Change from Baseline skin hydration at 4 weeks | Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydration. Units: arbitrary Corneometer® units 0-120. |
| The change of transepidermal water loss (TEWL) | Change from Baseline TEWL at 4 weeks | Tewameter® TM300 (CK, Germany) was utilized to measure the evaporation rate of water from the skin. Units: g/h/m\^2. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYAO PAN
Beijing Ewish Testing Technology Co.,ltd.
Outcome results
None listed