Status:
COMPLETED
Evaluation of the Anti-aging Efficacy of Two Dietary Supplements
Lead Sponsor:
Seppic
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
35-65 years
Phase:
NA
Brief Summary
The study is aimed to assess the efficacy of two dietary supplements composed of berry extracts in reducing skin aging signs and improving skin complexion.
Detailed Description
A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female subjects aged between 35 and 65 (±2) years old with phototypes from I to III, uneven skin tone, visible Cr...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Healthy female subjects,
- Caucasian ethnicity,
- Age between 35 and 65 (limits of ±2 years old could be included)
- Phototypes from I to III
- Subject with uneven skin tone (grade 1-3 - internal clinical scale)
- Subject with visible Crow's feet wrinkles (≥2 according to Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
- Subject with mild-moderate skin slackness at cheek level (grade 1-3 - internal clinical scale).
- Willingness to not assume during the study period products other than the test product
- Subjects registered with National Health Service (NHS)
- Subjects certifying the truthfulness of the personal data disclosed to the investigator
- Subjects able to understand the language used in the investigation centre and the information given by the investigator
- Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
- Commitment not to change the daily routine or the lifestyle
- Subjects who have not been recently involved in any other similar study (at least one month of wash-out)
- Subject under effective contraception (oral/not oral) therapy
- Subjects who accept not to expose in intensive way to UV rays during the whole study duration.
- Subject aware of the study procedures and having signed an informed consent form and privacy information form.
- Exclusion Criteria:
- Subject does not meet the inclusion criteria,
- Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects not able to be contacted in case of emergency
- Subjects admitted to a health or social facility
- Subjects planning a hospitalisation during the study
- Subjects who participated in a similar study without respecting an adequate washout period
- Subjects having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator
- Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Subject with known or suspected sensitization to one or more test formulation ingredients
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
- Consumption of food supplement(s) and/or use of topical skincare products with whitening activity currently or within the past 4 weeks before the study
- Subjects accustomed to use tanning beds
- Subjects taking medication with photosensitizing potential, drugs and/or dietary supplements able to induce skin coloring, corticoids, currently or during the month before the study.
Exclusion
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06032598
Start Date
September 25 2023
End Date
January 5 2024
Last Update
April 24 2024
Active Locations (1)
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1
Complife Italia srl
Milan, Italy, 20024