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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685096
• Other study ID #: 19E4487
• Status: Completed
• Start date: December 12, 2020
• Est. completion date: April 16, 2021

Study information

• Verified date: December 2020
• Source: Seneque SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 16, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Puffiness Around the Eyes
• Wrinkle

Intervention

Other:
• Test product creme
twice daily application of creme containing 2% NMN
• Reference creme
twice daily application of reference creme

Locations

Country	Name	City	State
China	Eurofins China	Guangzhou
United States	Eurofins CRL Cosmetics Inc	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Seneque SA	Eurofins, LGD

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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