Status:
COMPLETED
Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties
Lead Sponsor:
Seppic
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
30-60 years
Phase:
NA
Brief Summary
The study is aimed to assess the efficacy of two dietary supplements composed of a Wheat Polar Lipid Complex (WPLC) in reducing skin aging signs, in particular in improving firmness/elasticity, skin m...
Detailed Description
A double blind, parallel groups, placebo-controlled study is carried out on 72 healthy female subjects aged between 30 and 60 years old showing slight-moderate clinical signs of skin aging over the fa...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Healthy female subjects,
- Caucasian ethnicity,
- Age between 30 and 60 years old (extremes included),
- Wrinkles related to chronological ageing (from mild to moderate),
- Wrinkles related to photo-ageing (medium photo-ageing signs, dry and devitalized skin, asphyxia, pale and greyish skin, early ageing signs caused by a slowing in the cells activity),
- Subjects with dry skin defined with corneometric index \< 50 a.u.,
- Body mass index BMI between 19 and 30,
- At least 10 menopause women per group,
- Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the experimenter but at least 1 month must be elapsed between a previous study on food supplement),
- Willingness not to use chemical products or treatments on hair and nails (such as hair colour, straightening, permanent nail polish) in the two weeks preceding T56 visit,
- Willingness to not use during the study period products other than the test product,
- Willingness to not vary the normal diet and daily routine (at the beginning of the study volunteers list their usual routine: sport activities, sleeping habits, etc. ),
- Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial,
- Subjects who have not sun exposure (both natural or artificial) for at least two months
- Subjects who accept not to expose in intensive way to UV rays during the whole study duration,
- Willingness not to use similar products that could interfere with the product to be tested,
- Subject aware of the study procedures and having signed an informed consent form.
- Exclusion Criteria:
- Subject does not meet the inclusion criteria,
- Subject with known or suspected sensitization to one or more test formulation ingredients,
- Any condition that the principal investigator deems inappropriate for participation,
- Pregnant/breastfeeding female or who have planned a pregnancy during the study period,
- Pharmacological treatments (topic or systemic) known to interfere with skin metabolism/physiology,
- Lipid metabolism disorders (hypercholesterolemia, hyperlipidemia) and following treatment for theses disease,
- Subjects under locally pharmacological treatment on the skin area monitored during the test,
- Subjects under treatment with food supplements which could interfere with the functionality of the product under study,
- Subjects which show skin alterations on the monitored area which could interfere with the functionality of the product under study,
- Subjects who underwent to botox, hyaluronic acid, collagen injections or each type of facial surgery in the past 6 months,
- Severe concurrent diseases,
- Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated),
- Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function,
- Subjects resulting positive to Sars-Cov. 19 in the past 6 months/ during the study
- Subjects not presenting a valid Greenpass.
Exclusion
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06048354
Start Date
February 8 2022
End Date
July 1 2022
Last Update
September 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Complife Italia srl
Milan, Italy, 20024