Anti-ageing Efficacy of a Cosmetic Formulation Containing NMN (2%) Versus Placebo

Efficacy Evaluation of the Anti-ageing Effect of a Cosmetic Active Versus Placebo

The study aims at evaluating skin wrinkling, puffiness and fatigue and dark circle appearance on asian and african-american healthy volunteer cohorts receiving a cosmetic formulation containing NMN (2%). The product will be evaluated after 28 and 56 days of twice-daily application in comparison with a reference cosmetic formulation using clinical scoring under dermatological control. Cosmetic acceptability and future use will also be subjectively evaluated by analysis of the subjects answers to an evaluation questionnaire.

Study Overview

• Status: Completed
• Conditions: Fatigue; Wrinkle; Puffiness Around the Eyes
• Intervention / Treatment: Other: Test product creme; Other: Reference creme

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510289
    • Eurofins China
• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Eurofins CRL Cosmetics Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Type: Chinese and Afro-American subjects

• In each group, 50% of the subjects will have normal skin, 50% will have mild dry skin (declarative)
• 100% will have wrinkles or fine lines on the crow's feet
• 50% will have dark circles (half of them in the Active group, half of them in the Placebo group)
• 50% will have puffiness (half of them in the Active group, half of them in the Placebo)

Description

Inclusion Criteria:

• Healthy subject
• Subject having given her free informed, written consent
• Subject willing to adhere to the protocol and study procedures
• Subject with normal frontal temperature lower than 37.5°c/100.4°F
• Subject has read and understood the information given by the investigator related to protection against Novel Coronavirus 19 and necessity to contact the investigator in case of any suspicion of COVID related manifestation (increase of frontal temperature, cough, sore muscles, weakness…) during the study

Exclusion Criteria:

• Pregnant or nursing woman or woman planning to get pregnant during the study
• Start, stop or change in hormonal treatment (including contraceptive pill) <1.5 months
• Cutaneous pathology on the study zone (face)
• Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous efficacy of the study product
• Subject having undergone a surgery under general anesthesia within the previous month
• Know allergy to certain cosmetic or dermato-pharmaceutic products
• Subject having done injections on face and/or a lifting
• Excessive exposure to sunlight or UV-rays within the month preceding the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asian skin; Twice-daily application for 55 Days	Other: Test product creme; twice daily application of creme containing 2% NMN; Other: Reference creme; twice daily application of reference creme
African-American skin; Twice-daily application for 55 Days	Other: Test product creme; twice daily application of creme containing 2% NMN; Other: Reference creme; twice daily application of reference creme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkles	clinical grading under dermatological control using 1) a 7 points Visual scale of Bazin from absence (0) to pronounced wrinkles (6) for the Asian panel and 2) a 5 points Visual scale of Bazin from absence (0) to pronounced wrinkles (4) for the Afro-American panel	Change from baseline (day 0) at days 28 and 56 of application
Eye bags	clinical grading under dermatological control using 1) a 7 points Visual scale of Bazin from absence (0) to pronounced bags (6) for the Asian panel and 2) a 6 points Visual scale of Bazin from absence (0) to pronounced bags (5) for the Afro-American panel	Change from baseline (day 0) at days 28 and 56 of application
Dark circles	clinical grading under dermatological control using 1) a 6 points Visual scale of Dermscan from absence (0) to important dark circles (6) for the Asian panel and 2) a 5 points Visual scale of Dermscan from absence (0) to important dark circles (4) for the Afro-American panel	Change from baseline (day 0) at days 28 and 56 of application
Relaxed features	clinical grading under dermatological control using a 11 points Non structured scale from relaxed features (0) to looking tired (10) for both panels	Change from baseline (day 0) at days 28 and 56 of application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone.	Self-assessment questionnaire on a 5 points scale from "I disagree" (-2) to "I agree" (+2).	At day 28 of application
Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone.	Self-assessment questionnaire on a 5 points scale from "I disagree" (-2) to "I agree" (+2).	At day 56 of application

Collaborators and Investigators

• Sponsor: Seneque SA
• Collaborators: Eurofins; LGD
• Investigators: Study Director: Corinne BENIER, Dermscan

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2020
• Primary Completion (ACTUAL): March 12, 2021
• Study Completion (ACTUAL): April 16, 2021

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (ACTUAL): December 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Skin aging
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 19E4487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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