Evaluation of the Anti-aging Efficacy of Two Dietary Supplements

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Berry extract 1; Dietary supplement: Berry extract 2; Dietary supplement: Placebo

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphanie Dudonné; Phone Number: + 33 563726744; Email: stephanie.dudonne@airliquide.com

Study Locations

• Italy
  • Milano, Italy, 20024
    • Recruiting
    • Complife Italia srl
    • Contact: Ileana De Ponti; Phone Number: +39 382490286; Email: ileana.deponti@complifegroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Dietary supplement - Placebo	Dietary supplement: Placebo; The study foresees the intake of 1 capsule per day during 84 days
Experimental: Berry extract 1; Dietary supplement - Berry extract 1	Dietary supplement: Berry extract 1; The study foresees the intake of 1 capsule per day during 84 days
Experimental: Berry extract 2; Dietary supplement - Berry extract 2	Dietary supplement: Berry extract 2; The study foresees the intake of 1 capsule per day during 84 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin profilometry	Primos 3D	Baseline
Skin profilometry	Primos 3D	28 days
Skin profilometry	Primos 3D	56 days
Skin profilometry	Primos 3D	84 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seppic
• Investigators: Study Director: Ileana De Ponti, Complife Italia S.r.l

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IT0003588/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No