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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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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).
Primary purpose
Allocation
Interventional model
Masking
108 participants in 3 patient groups, including a placebo group
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Central trial contact
Arnaud JACQUOT (Clinical Affairs Manager), M. Sc; Lionel NOAH (Senior Scientific Manager), Ph. D.
Data sourced from clinicaltrials.gov
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