Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women

Study Overview
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Brief Summary
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The goal of this clinical trial is to study the efficacy of collagen supplement on the moisture content and elasticity. 70 participants of 30-50 years old women will be enrolled from two study sites and randomly assigned to use two products (study product plus collagen supplement and placebo product without collagen supplement) for 2 months. Researchers will compare the two groups to validate the assumption that there is significant improvement on skin anti-aging effect for participants using study product plus collagen supplement.

Detailed Description
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This study is two arms, randomized, double-blind controlled trial. There will be two study sites and 35 eligible participants at each study site will be enrolled with the expectation of having 30 participants completed per study group. Particants will be randomly allocated to use one of the two study products defined in the trial protocol for two months. Up to three study visits will be made by the participant over a 2-month period. All relevant data will be captured and recorded into CTMS (Clinical Trial Management System). The data will be analyzed and reported after the completion of the study.

Official Title
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A Randomized, Double Blind, Controlled Study of Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women

Conditions
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Skin Laxity, Skin Lines

Intervention / Treatment
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* Dietary Supplement: Study product plus collagen supplement
* Dietary Supplement: Study product without collagen supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese females, age between 30-50; Be in general good health; Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate; Have mild to moderate darker skin tone 3 on Unilever visual scale of 1 9; Have mild pigmentation level 2 on Unilever visual scale of 0 9; Have visual grading score on crow's feet 3 on Unilever visual scale of 0 9; Have visual grading score on peri-oral 3 on Unilever visual scale of 0 9; Have visual grading score on nasolabial folds 3 on Unilever visual scale of 0 9; Tolerate to well-known anti-aging actives; Agree to not use any other creams, lotions, moisturizers on the face, other than what is provided for the duration of the study; Agree to refrain from wearing make-up (such as foundation, eye shadow, lipstick etc.) or any skin care products on the face on the study visits; Agree to avoid washing the treatment site area for two hours following product application and agree to avoid washing appliances (i.e., sponge, wash cloth, loofah, etc.). Exclusion Criteria: Have used any skin lightening /anti-aging benefits products at least one month before this study Subject having done facial injections and/or aesthetic surgery. Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product. Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently. Have a history of any type of bagcer, including but not limited to any type of skin bagcer (squamous or basal cell carcinoma at the treatment site) or history of malignant melanoma at any body site. Have a history of skin disease or the presence of a skin condition on the test sites that the Investigator feels would interfere with the study. Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment. Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, pregnancy, lactation. Have any cuts/abrasions on the test site at baseline. Have had a suspicious skin lesion removed by a dermatologist at any time. The subject is an employee of sponsor or the site conducting the study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study product plus collagen supplement<br>5g/bag, containing the following ingredients per 5g serving: Collagen tripeptide 1500 mg Elastin peptide 150 mg | Dietary Supplement: Study product plus collagen supplement<br>* The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.<br>|
| Placebo Comparator: Study product without collagen supplement<br>5g/bag, containing the following ingredients per 5g serving: Peach juice 8 mg Erythritol 10 mg | Dietary Supplement: Study product without collagen supplement<br>* The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Elasticity | The changes of skin elasticity from baseline to day 60 by CK Cutometer MPA580 | baseline day 0, day 60 | 
| Skin Moisture | The changes of skin moisture from baseline to day 60 by Corneometer CM 825 | baseline day 0, day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Barrier | The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200 | baseline day 0, day 30, day 60 | 
| Lines/Wrinkles | The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system | baseline day 0, day 30, day 60 | 
| Facial Glow | The changes of Facial Glow by expert visual assessment | baseline day 0, day 30, day 60 | 
| Skin Diagnosis | The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System | baseline day 0, day 30, day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Collagen, skin anti-aging, skin moisture, skin elasticity