Fatigue, Puffiness Around the Eyes, Wrinkle
Conditions
Keywords
Skin aging
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.
Interventions
OTHERTest product creme
twice daily application of creme containing 2% NMN
OTHERReference creme
twice daily application of reference creme
Sponsors
Eurofins
LGD
Seneque SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China, United States
Outcome results
None listed