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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04685096
Other study ID # 19E4487
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 12, 2020
Est. completion date April 16, 2021

Study information

Verified date December 2020
Source Seneque SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date April 16, 2021
Est. primary completion date March 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Test product creme
twice daily application of creme containing 2% NMN
Reference creme
twice daily application of reference creme

Locations

Country Name City State
China Eurofins China Guangzhou
United States Eurofins CRL Cosmetics Inc Piscataway New Jersey

Sponsors (3)

Lead Sponsor Collaborator
Seneque SA Eurofins, LGD

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone. Self-assessment questionnaire on a 5 points scale from "I disagree" (-2) to "I agree" (+2). At day 28 of application
Secondary Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone. Self-assessment questionnaire on a 5 points scale from "I disagree" (-2) to "I agree" (+2). At day 56 of application
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