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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04685096
Recruitment Status : Completed
First Posted : December 28, 2020
Last Update Posted : April 23, 2021
Sponsor:
Collaborators:
Eurofins
LGD
Information provided by (Responsible Party):
Seneque SA

Study Description
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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
Wrinkle Fatigue Puffiness Around the Eyes Other: Test product creme Other: Reference creme

Study Design
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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 : December 12, 2020
Actual Primary Completion Date : March 12, 2021
Actual Study Completion Date : April 16, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Wrinkles [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: At day 56 of application ]
    Self-assessment questionnaire on a 5 points scale from "I disagree" (-2) to "I agree" (+2).


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685096


Locations
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United States, New Jersey
Eurofins CRL Cosmetics Inc
Piscataway, New Jersey, United States, 08854
China
Eurofins China
Guangzhou, China, 510289
Sponsors and Collaborators
Seneque SA
Eurofins
LGD
Investigators
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Study Director: Corinne BENIER Dermscan
More Information
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Responsible Party: Seneque SA
ClinicalTrials.gov Identifier: NCT04685096    
Other Study ID Numbers: 19E4487
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seneque SA:
Skin aging
Additional relevant MeSH terms:
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Fatigue