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Completed

NCT Number: NCT04685096

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Eurofins China, Guangzhou, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test product creme

Other

twice daily application of creme containing 2% NMN

Reference creme

Other

twice daily application of reference creme

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Seneque SA

Industry

Collaborators

  • Eurofins
  • LGD

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2020
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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