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

Sponsor
Seneque SA (Industry)
Overall Status
Completed
CT.gov ID
NCT04685096
Collaborator
Eurofins (Industry), LGD (Industry)
89
2
4.1
44.5
10.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Test product creme
  • Other: Reference creme

Study Design

Study Type:
Observational
Actual Enrollment :
89 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Efficacy Evaluation of the Anti-ageing Effect of a Cosmetic Active Versus Placebo
Actual Study Start Date :
Dec 12, 2020
Actual Primary Completion Date :
Mar 12, 2021
Actual Study Completion Date :
Apr 16, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

Secondary Outcome Measures

  1. 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]

    Self-assessment questionnaire on a 5 points scale from "I disagree" (-2) to "I agree" (+2).

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eurofins CRL Cosmetics Inc Piscataway New Jersey United States 08854
2 Eurofins China Guangzhou China 510289

Sponsors and Collaborators

  • Seneque SA
  • Eurofins
  • LGD

Investigators

  • Study Director: Corinne BENIER, Dermscan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seneque SA
ClinicalTrials.gov Identifier:
NCT04685096
Other Study ID Numbers:
  • 19E4487
First Posted:
Dec 28, 2020
Last Update Posted:
Apr 23, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seneque SA
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 23, 2021