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

Completed

• Conditions: Fatigue; Wrinkle; Puffiness Around the Eyes
• Interventions: Other: Test product creme; Other: Reference creme

• Registration Number: NCT04685096
• Lead Sponsor: Seneque SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-11
• Study Start: 2020-12-12
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Primary Completion: 2021-03-12
• Study Completion: 2021-04-16
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asian skin	Reference creme	Twice-daily application for 55 Days
African-American skin	Reference creme	Twice-daily application for 55 Days
Asian skin	Test product creme	Twice-daily application for 55 Days
African-American skin	Test product creme	Twice-daily application for 55 Days

Primary Outcome Measures

Name	Time	Method
Wrinkles	Change from baseline (day 0) at days 28 and 56 of application	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
Relaxed features	Change from baseline (day 0) at days 28 and 56 of application	clinical grading under dermatological control using a 11 points Non structured scale from relaxed features (0) to looking tired (10) for both panels
Eye bags	Change from baseline (day 0) at days 28 and 56 of application	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
Dark circles	Change from baseline (day 0) at days 28 and 56 of application	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Eurofins CRL Cosmetics Inc; 🇺🇸 Piscataway, New Jersey, United States

Eurofins China; 🇨🇳 Guangzhou, China