Evaluation of the Anti-aging Efficacy of Two Dietary Supplements

Healthy Volunteers Clinical Trial

Official title:

Clinical-instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties and Skin Complexion Improvement. A Double-blind, Randomized, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06032598
• Other study ID #: IT0003588/23
• Status: Completed
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: January 5, 2024

Study information

• Verified date: August 2023
• Source: Seppic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Crow's feet wrinkles and mild-moderate skin slackness at cheek level.

The study foresees 84 days of products intake. Evaluations of the parameters under study are performed at baseline, after 28, 56 and 84 days of products consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Berry extract 1
The study foresees the intake of 1 capsule per day during 84 days
• Berry extract 2
The study foresees the intake of 1 capsule per day during 84 days
• Placebo
The study foresees the intake of 1 capsule per day during 84 days

Locations

Country	Name	City	State
Italy	Complife Italia srl	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Seppic

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin profilometry	Primos 3D	Baseline
Primary	Skin profilometry	Primos 3D	28 days
Primary	Skin profilometry	Primos 3D	56 days
Primary	Skin profilometry	Primos 3D	84 days
Secondary	Skin elasticity	Cutometer	Baseline
Secondary	Skin elasticity	Cutometer	28 days
Secondary	Skin elasticity	Cutometer	56 days
Secondary	Skin elasticity	Cutometer	84 days
Secondary	Skin color	CIELab color space	Baseline
Secondary	Skin color	CIELab color space	28 days
Secondary	Skin color	CIELab color space	56 days
Secondary	Skin color	CIELab color space	84 days
Secondary	Crow's feet	Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)	Baseline
Secondary	Crow's feet	Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)	28 days
Secondary	Crow's feet	Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)	56 days
Secondary	Crow's feet	Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)	84 days
Secondary	Skin firmness	Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin)	Baseline
Secondary	Skin firmness	Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin)	28 days
Secondary	Skin firmness	Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin)	56 days
Secondary	Skin firmness	Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin)	84 days
Secondary	Skin homogeneity improvment from baseline	Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation)	28 days
Secondary	Skin homogeneity improvment from baseline	Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation)	56 days
Secondary	Skin homogeneity improvment from baseline	Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation)	84 days
Secondary	Self-assessment of product efficacy	Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)	84 days
Secondary	Skin antioxidant potential	FRAP (Ferric Reducing Antioxidant Power) assay	Baseline
Secondary	Skin antioxidant potential	FRAP (Ferric Reducing Antioxidant Power) assay	84 days