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| Name | Class |
|---|---|
| Eurofins Dermscan Pharmascan | INDUSTRY |
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The study is being conducted to evaluate the efficacy and the safety of an oral acerola-based product on skin ageing parameters.
The main objective of this study is to assess efficacy of the product on skin translucency after 84 days of product compared to a placebo. The study will also evaluate the effect of the product on different skin parameters (radiance, firmness, elasticity, skin barrier function, skin pH, blood flow) with different instruments. The quality of life and the improvement of skin properties will also be collected with questionnaires completed by the subjects. Finally, the safety of this product will be assessed by collecting all adverse events that might occur during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acerola Juice Powder 1200 mg/day | Experimental | Higher dose |
|
| Acerola Juice Powder 600 mg/day | Experimental | Lower dose |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acerola Juice Powder 1200 mg/day | Dietary Supplement | 4 capsules per day, each capsule containing 300mg of Acerola and 100 mg of maltodextrin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on skin translucency parameter Alpha at 84 days | The skin translucency parameter Alpha is measured with translucency meter | From enrollment to 84 days of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on skin translucency parameters Alpha, Area and K at 28 days and 84 days | The skin translucency parameters Alpha, Area and Kis are measured with translucency meter | From enrollment to 28 days of supplementation |
| Change from baseline on skin complexion radiance at 14, 28, 56 and 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on skin pH at 28 and 84 days | Skin pH measured with pH meter | From enrollment to 28 and 84 days of supplementation |
| Change from baseline on blood flow at 28 and 84 days | Blood flow measured with Laser speckle blood flow imager® |
Inclusion Criteria:
Healthy women.
Chinese.
Age: in each group of products
Phototype: II to IV.
Subject with dull skin from grade 3 to 7 on skin dullness 9 points scale.
Subject exposed to high air pollution up to 2 to 3 hours per day (traffic roads, cigarette smoke, dusts or small particles).
Subject who accepts daily exposition to blue light (mobile phone, Ipad, laptop or get exposure to LED light) at home (at least 2h).
Subject with at least 1 spot on the face.
Subject with BMI ≤ 30
Subject, psychologically able to understand the study related information and to give a written informed consent.
Subject having given freely and expressly her informed consent.
Subject agreeing to not change her alimentary and cosmetic habits on the studied area during the study.
Exclusion Criteria:
In term of population :
Pregnant or nursing woman or planning a pregnancy during the study.
Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
Minor subject.
Major subject who is under guardianship or who is not able to express her consent.
Subject in a social or sanitary establishment.
Subject suspected to be non-compliant according to the investigator's judgment.
In term of associated pathology :
Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
Subject suffering from a severe or progressive disease.
Subject with known history of or suffering from skin disease that may interfere with evaluation of the study results and/or subject safety.
Subject having history of severe allergy or anaphylactic shock including known risk of hypersensitivity to one of the components of the composition of the product
Related to previous or ongoing treatment :
Subject undergoing a topical treatment on the test area or a systemic treatment:
Subject having started or changed her oral contraceptive or any other hormonal treatment during the three previous months.
Subject having done facial skin care like peeling, mask… during the previous 2 weeks and during the study.
Subject having used oral nutritional supplements and/or vitamin supplementation during the previous month and during the study
In term of lifestyle :
Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study;
Subject having used topical products containing actives substances during the previous 2 weeks and during the study
Subject planning to change her life habits during the study.
Subject with unstable eating habits or planning to change them during the study
Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 5 cigarettes per day).
Female
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| Name | Affiliation | Role |
|---|---|---|
| Sarah ZENG | EUROFINS CONSUMER PRODUCT TESTING (Guangzhou)Co.,Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EUROFINS CONSUMER PRODUCT TESTING (Guangzhou)Co.,Ltd. | Guangzhou | China |
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Double-blind, randomised, placebo-controlled study
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| Acerola Juice Powder 600 mg/day | Dietary Supplement | 4 capsules/day, each capsule containing 150 mg of Acerola and 250 mg of Maltodextrin |
|
| Placebo | Other | 4 capsules per day, each capsule containing 400 mg of maltodextrin |
|
Skin complexion radiance measured with Colorface® |
| From enrollment to 14, 28, 56 and 84 days of supplementation |
| Change from baseline on pigment spot at 14, 28, 56 and 84 days | Pigment spot measured with Colorface® | From enrollment to 14, 28, 56 and 84 days of supplementation |
| Change from baseline on skin firmness, elasticity and fatigability at 28 and 84 days | Skin firmness, elasticity and fatigability measured with Cutometer® | From enrollment to 28 and 84 days of supplementation |
| Change from baseline on Trans Epidermal Water Loss at 28 and 84 days | Trans Epidermal Water Loss measured with Tewameter® | From enrollment to 28 and 84 days of supplementation |
| Product safety | Safety assessed by the collection of adverse events and concomitant treatments throughout the study | From enrolment to 84 days |
| From enrollment to 28 and 84 days of supplementation |
| Change from baseline on subject quality of life at 28 and 84 days | Quality of life assessed using the questionnaire SF-12 completed by the subjects | From enrollment to 28 and 84 days of supplementation |
| Change from baseline on subject satisfaction at 28 and 84 days | Subject satisfaction assessed with a subjective evaluation questionnaire developed by the Sponsor completed by the subjects | From enrollment to 28 and 84 days of supplementation |