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

NCT04685096 | Completed

• 1 other identifier: 19E4487
• Study Type: observational
• Target: 89
• Locations: 2 countries
• Sites: 2

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.

Conditions

Wrinkle; Fatigue; Puffiness Around the Eyes

Keywords

Skin aging

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone.

  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.

  At day 56 of application

Study Arms (2)

Asian skin

Twice-daily application for 55 Days

Other: Test product creme; Other: Reference creme

African-American skin

Twice-daily application for 55 Days

Other: Test product creme; Other: Reference creme

Interventions

Test product creme OTHER

twice daily application of creme containing 2% NMN

African-American skin; Asian skin

Reference creme OTHER

twice daily application of reference creme

African-American skin; Asian skin

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seneque SA: lead
• Eurofins: collaborator
• LGD: collaborator

Study Sites (2)

Eurofins CRL Cosmetics Inc

Piscataway, New Jersey, 08854, United States

Location

Eurofins China

Guangzhou, 510289, China

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Corinne BENIER

  Dermscan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 28, 2020
• Study Start: December 12, 2020
• Primary Completion: March 12, 2021
• Study Completion: April 16, 2021
• Last Updated: April 23, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CN (1)