- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07229131
Effect of an Oral Acerola Juice Powder on Skin Beauty Parameters in Women Exposed to Environmental Stresses
Effect of an Oral Acerola Juice Powder on Skin Beauty Parameters in Women Exposed to Environmental Stresses: A Double-blind, Randomised, Placebo-controlled Study.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Guangzhou, China
- EUROFINS CONSUMER PRODUCT TESTING (Guangzhou)Co.,Ltd.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy women.
- Chinese.
Age: in each group of products
- 50% of subject having 30 to 45 years old
- 50% of subject having 46 to 60 years old
- 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:
- anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study;
- corticosteroids during the 2 previous weeks and during the study;
- retinoids and/or immunosuppressors during the 3 previous months and during the study;
- any medication stabilized for less than one month.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
4 capsules per day, each capsule containing 400 mg of maltodextrin
|
|
Experimental: Acerola Juice Powder 1200 mg/day
Higher dose
|
4 capsules per day, each capsule containing 300mg of Acerola and 100 mg of maltodextrin
|
|
Experimental: Acerola Juice Powder 600 mg/day
Lower dose
|
4 capsules/day, each capsule containing 150 mg of Acerola and 250 mg of Maltodextrin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline on skin translucency parameter Alpha at 84 days
Time Frame: From enrollment to 84 days of supplementation
|
The skin translucency parameter Alpha is measured with translucency meter
|
From enrollment to 84 days of supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline on skin translucency parameters Alpha, Area and K at 28 days and 84 days
Time Frame: From enrollment to 28 days of supplementation
|
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
Time Frame: From enrollment to 14, 28, 56 and 84 days of supplementation
|
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
Time Frame: From enrollment to 14, 28, 56 and 84 days of supplementation
|
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
Time Frame: From enrollment to 28 and 84 days of supplementation
|
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
Time Frame: From enrollment to 28 and 84 days of supplementation
|
Trans Epidermal Water Loss measured with Tewameter®
|
From enrollment to 28 and 84 days of supplementation
|
|
Product safety
Time Frame: From enrolment to 84 days
|
Safety assessed by the collection of adverse events and concomitant treatments throughout the study
|
From enrolment to 84 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline on skin pH at 28 and 84 days
Time Frame: From enrollment to 28 and 84 days of supplementation
|
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
Time Frame: From enrollment to 28 and 84 days of supplementation
|
Blood flow measured with Laser speckle blood flow imager®
|
From enrollment to 28 and 84 days of supplementation
|
|
Change from baseline on subject quality of life at 28 and 84 days
Time Frame: From enrollment to 28 and 84 days of supplementation
|
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
Time Frame: From enrollment to 28 and 84 days of supplementation
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah ZENG, EUROFINS CONSUMER PRODUCT TESTING (Guangzhou)Co.,Ltd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GZ25205020P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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