Clinical trial NCT04685096: Anti-ageing Efficacy of a Cosmetic Formulation Containing NMN (2%) Versus Placebo
Official title: Efficacy Evaluation of the Anti-ageing Effect of a Cosmetic Active Versus Placebo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wrinkle
Fatigue
Puffiness Around the Eyes
Keywords: Skin aging
Lead sponsor: Seneque SA
Sponsor class: INDUSTRY
Collaborators: name: Eurofins
name: LGD
First posted: 2020-12-28
Enrollment: 89
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility 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

Primary outcomes:
measure: Wrinkles
timeFrame: Change from baseline (day 0) at days 28 and 56 of application
measure: Eye bags
timeFrame: Change from baseline (day 0) at days 28 and 56 of application
measure: Dark circles
timeFrame: Change from baseline (day 0) at days 28 and 56 of application
measure: Relaxed features
timeFrame: Change from baseline (day 0) at days 28 and 56 of application
Secondary outcomes:
measure: Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone.
timeFrame: At day 28 of application
measure: Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone.
timeFrame: At day 56 of application
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Eurofins CRL Cosmetics Inc
state: New Jersey
city: Guangzhou
country: China
facility: Eurofins China
Study officials:
affiliation: Dermscan
name: Corinne BENIER
role: STUDY_DIRECTOR
References: