Last updated: September 15, 2023
Sponsor: Seppic
Overall Status: Completed
Phase
N/A
Condition
Healthy Volunteers
Treatment
Placebo
Wheat Polar Lipid Complex Powder
Wheat Polar Lipid Complex Oil
Clinical Study ID
NCT06048354
IT0003398/21
Ages 30-60 Female Accepts Healthy Volunteers
Study Summary
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 cellsactivity),
- 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 isperformed case by case by the experimenter but at least 1 month must be elapsedbetween a previous study on food supplement),
- Willingness not to use chemical products or treatments on hair and nails (such as haircolour, 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 thestudy volunteers list their usual routine: sport activities, sleeping habits, etc. ),
- Subjects under effective contraception (oral/not oral) if women of childbearingpotential; not expected to be changed during the trial,
- Subjects who have not sun exposure (both natural or artificial) for at least twomonths
- Subjects who accept not to expose in intensive way to UV rays during the whole studyduration,
- Willingness not to use similar products that could interfere with the product to betested,
- Subject aware of the study procedures and having signed an informed consent form.
Exclusion
Exclusion Criteria:
- Subject does not meet the inclusion criteria,
- Subject with known or suspected sensitization to one or more test formulationingredients,
- 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 skinmetabolism/physiology,
- Lipid metabolism disorders (hypercholesterolemia, hyperlipidemia) and followingtreatment for theses disease,
- Subjects under locally pharmacological treatment on the skin area monitored during thetest,
- Subjects under treatment with food supplements which could interfere with thefunctionality of the product under study,
- Subjects which show skin alterations on the monitored area which could interfere withthe functionality of the product under study,
- Subjects who underwent to botox, hyaluronic acid, collagen injections or each type offacial surgery in the past 6 months,
- Severe concurrent diseases,
- Adult protected by the law (under guardianship, or hospitalized in a public or privateinstitution, for a reason other than the research, or incarcerated),
- Subject is unable to communicate or cooperate with the Investigator due to languageproblems, 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.
Study Design
Total Participants: 72
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
February 08, 2022
Estimated Completion Date:
July 01, 2022
Study Description
Connect with a study center
Complife Italia srl
Milano, 20024
ItalySite Not Available
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