Evaluation of the Anti-aging Efficacy of Two Dietary Supplements

NCT06032598 | Completed

• 1 other identifier: IT0003588/23
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Skin profilometry

  Primos 3D

  Baseline

• Skin profilometry

  Primos 3D

  28 days

• Skin profilometry

  Primos 3D

  56 days

• Skin profilometry

  Primos 3D

  84 days

Secondary Outcomes (22)

• Skin elasticity

  Baseline

• Skin elasticity

  28 days

• Skin elasticity

  56 days

• Skin elasticity

  84 days

• Skin color

  Baseline

Study Arms (3)

Berry extract 1

EXPERIMENTAL

Dietary supplement - Berry extract 1

Dietary Supplement: Berry extract 1

Berry extract 2

EXPERIMENTAL

Dietary supplement - Berry extract 2

Dietary Supplement: Berry extract 2

Placebo

PLACEBO COMPARATOR

Dietary supplement - Placebo

Dietary Supplement: Placebo

Interventions

Berry extract 1 DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 84 days

Berry extract 1

Berry extract 2 DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 84 days

Berry extract 2

Placebo DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 84 days

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seppic: lead

Study Sites (1)

Complife Italia srl

Milan, 20024, Italy

Location

Study Officials

• Ileana De Ponti

  Complife Italia S.r.l

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: September 25, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: April 24, 2024

Record last verified: 2023-08

Locations

IT (1)