WrinkleNCT04685096
Anti-ageing Efficacy of a Cosmetic Formulation Containing NMN (2%) Versus Placebo
An observational study of Wrinkle and Fatigue, run by Seneque SA at 2 sites in 2 countries.
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%). Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Fatigue, Puffiness Around the Eyes
- What is being tested?
- Test product creme and Reference creme
- How many people
- 89 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Dec 2020to 16 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Eurofins CRL Cosmetics Inc
Piscataway, New Jersey, 08854
About this study
Official title: Efficacy Evaluation of the Anti-ageing Effect of a Cosmetic Active 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.
- Conditions
- Wrinkle, Fatigue, Puffiness Around the Eyes
- Being tested
- Test product creme, Reference creme
- Keywords
- Skin aging
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product cremeOther
twice daily application of creme containing 2% NMN
Reference cremeOther
twice daily application of reference creme
| Study group | Role | What they receive |
|---|---|---|
| Asian skin | Twice-daily application for 55 Days Receives: Other: Test product creme; Other: Reference creme | |
| African-American skin | Twice-daily application for 55 Days Receives: Other: Test product creme; Other: Reference creme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline (day 0) at days 28 and 56 of application
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
Measured: Change from baseline (day 0) at days 28 and 56 of application
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
Measured: Change from baseline (day 0) at days 28 and 56 of application
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
Measured: Change from baseline (day 0) at days 28 and 56 of application
Secondary outcomes (2)
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).
Measured: At day 28 of application
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).
Measured: At day 56 of application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start12 Dec 2020
- Primary completion12 Mar 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seneque SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins, LGD
- Responsible party
- Sponsor
- Investigators
- Corinne BENIER, Study director, Dermscan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685096
- Sponsor's protocol ID
- 19E4487
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of the Anti-ageing Effect of a Cosmetic Active Versus Placebo
- ClinicalTrials.gov ID
- NCT04685096
- Acronym / sponsor ID
- 19E4487
- Conditions
- Wrinkle, Fatigue, Puffiness Around the Eyes
- Keywords
- Skin aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Seneque SAIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins, LGD
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asian skin | – | Other: Test product creme, Other: Reference cremeTwice-daily application for 55 Days |
| African-American skin | – | Other: Test product creme, Other: Reference cremeTwice-daily application for 55 Days |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test product cremetwice daily application of creme containing 2% NMN | Other | African-American skin, Asian skin |
| Reference cremetwice daily application of reference creme | Other | African-American skin, Asian skin |
Primary outcome
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
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
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne BENIER study director
Dermscan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkle and Fatigue, run by Seneque SA at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrinkles (time frame: Change from baseline (day 0) at days 28 and 56 of application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.