HealthyNCT06433323
Biological Anti-aging Efficacy of a Cosmetic Night Cream
An observational study of Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
In a previous study, the cosmetic night cream RV4983A- LA3365 has proven a great efficacy in reducing the clinical signs of skin aging, as well as a great tolerance. The skin structure and composition greatly evolve over the time, and deciphering the biological mechanisms by which the cosmetic night cream RV4983A… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Anti-aging cosmetic care product
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2024to 26 Jul 2024
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy female volunteers.
Who may be able to join
- Subject with phototype I, II or III according to the Fitzpatrick scale
- Non-inclusion Criteria:
- Criteria related to the subject's health / skin :
- Subject having any dermatologic condition or characteristics (like tattoo) on any of the target areas liable to interfere with the study assessments
- Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Subject having received on any of target areas artificial UV exposure, excessive or prolonged exposure to natural sunlight within 2 weeks before the inclusion visit or planning to be exposed to artificial UV, excessive or prolonged natural sunlight during the study and up to 3 months after completion of study participation
Show all 24Show fewer
- Subject hirsute on the target areas
- Subject having contraindication to the local anaesthetic used for biopsies
- Subject with known immune deficiency
- Subject with a recognised addiction to alcohol or drug
- Subject with a scar pathology or pathology with consequences for healing such as diabetes
- Subject with known history of hepatitis B or C or known HIV positive status
- Subject with hereditary or acquired haemostasis disorder
- Smoker > 10 cigarettes/day with nicotine (or equivalent in electronic cigarettes)
- Criteria related to treatments and/or products:
- Surgical, chemical or significant invasive treatment on any of the target areas within 6 months before the inclusion or planned during the study
- Techniques with aesthetic aim on any of the target areas (laser, pulsed flash lamp etc.) or injections of reshaping products (collagen, hyaluronic acid, botulinic toxin etc.) within 6 months before the inclusion or planned during the study
- Oral isotretinoin taken within 6 months before the inclusion or planned during the study
- Phototherapy treatment on any of the target areas within 2 months before the inclusion or planned during the study
- Systemic treatment likely to affect haemostasis (anticoagulants, platelet antiaggregants, etc.) taken within the weeks before the inclusion or planned during the study
- Systemic treatment may interfere with the healing process (non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressants) taken within the weeks before the inclusion or planned during the study
- Systemic treatment or topical treatment applied on any target areas likely to interfere with the local anesthetic (anti-arhythmic, beta blockers etc.) within the weeks before the inclusion or planned during the study
- Topical non-steroidal anti-inflammatory, dermocorticoids, immunomodulators applied on any of the target areas within the 2 weeks before the inclusion or planned during the study
- Topical skincare product (e.g. exfoliation, scrub, body mask) applied on any of the target areas within 7 days before the inclusion or planned during the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Biological Anti-aging Efficacy of the Cosmetic Night Cream RV4983A- LA3365 in Women After 2 Months of Daily Use
In a previous study, the cosmetic night cream RV4983A- LA3365 has proven a great efficacy in reducing the clinical signs of skin aging, as well as a great tolerance. The skin structure and composition greatly evolve over the time, and deciphering the biological mechanisms by which the cosmetic night cream RV4983A- LA3365 reduces the signs of skin aging is therefore of great interest to deepen our efficacy evaluation and knowledge on skin aging biology.
Read the detailed description
An intra-individual, comparative study randomized will be conducted as monocentric trial in female adult
46 subjects are included
4 visits are planned:
- Visit 1 (D1): Inclusion and 1st product application
- Visit 2 (D28): Phone call follow-up
- Visit 3 (D57): End of application and biopsies
- Visit 4 (7 days after V3): Biopsies control and end-of-study
For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum.
The maximal duration of participation for a subject is 68 days.
- Conditions
- Healthy
- Being tested
- Anti-aging cosmetic care product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-aging cosmetic care productOther
This is an intra-individual comparison study.
- frequency of application: Once a day (in the evening)
- modalities of application: Apply the cream on the tested area determined by the randomization
- duration of investigational product application: 56 days (a window of + 72 hours is allowed)
| Study group | Role | What they receive |
|---|---|---|
| Treated group : Healthy female adults | Not described Receives: Other: Anti-aging cosmetic care product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological efficacy assessed by the analysis of proteins expression related to aging.
Will be determined from skin biopsies.
Measured: Day 57
General safety assessed by the occurence of Adverse Events.
The occurrence of Adverse Events will be determined by the subject's spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation.
Measured: Day 1 to Day 68
Compliance calculated from data reported by the subject in her diary.
Measured: Day 1 to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start23 May 2024
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SpinControl
- Responsible party
- Sponsor
- Investigators
- Elisabeth GUITTON-OUDET, Dr, Principal investigator, SpinControl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433323
- Sponsor's protocol ID
- RV4983A20240122
- Status last verified
- Dec 2024
- First submitted
- 22 May 2024
- Last updated
- 10 Dec 2024
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biological Anti-aging Efficacy of the Cosmetic Night Cream RV4983A- LA3365 in Women After 2 Months of Daily Use
- ClinicalTrials.gov ID
- NCT06433323
- Acronym / sponsor ID
- RV4983A20240122
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Collaborators
- SpinControl
- Study start
- 23 May 2024 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 29 May 2024 (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.
In a previous study, the cosmetic night cream RV4983A- LA3365 has proven a great efficacy in reducing the clinical signs of skin aging, as well as a great tolerance. The skin structure and composition greatly evolve over the time, and deciphering the biological mechanisms by which the cosmetic night cream RV4983A- LA3365 reduces the signs of skin aging is therefore of great interest to deepen our efficacy evaluation and knowledge on skin aging biology.
Detailed description
An intra-individual, comparative study randomized will be conducted as monocentric trial in female adult
46 subjects are included
4 visits are planned:
- Visit 1 (D1): Inclusion and 1st product application
- Visit 2 (D28): Phone call follow-up
- Visit 3 (D57): End of application and biopsies
- Visit 4 (7 days after V3): Biopsies control and end-of-study
For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum.
The maximal duration of participation for a subject is 68 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated group : Healthy female adults | – | Other: Anti-aging cosmetic care product |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy female volunteers.
Key inclusion criteria (24 listed)
- Subject with phototype I, II or III according to the Fitzpatrick scale
- Criteria related to the subject's health / skin :
- Criteria related to treatments and/or products:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Anti-aging cosmetic care productThis is an intra-individual comparison study. * frequency of application: Once a day (in the evening) * modalities of application: Apply the cream on the tested area determined by the randomization * duration of investigational product application: 56 days (a window of + 72 hours is allowed) | Other | Treated group : Healthy female adults |
Primary outcome
Biological efficacy assessed by the analysis of proteins expression related to aging.
Time frame: Day 57
Will be determined from skin biopsies.
General safety assessed by the occurence of Adverse Events.
Time frame: Day 1 to Day 68
The occurrence of Adverse Events will be determined by the subject's spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation.
Compliance calculated from data reported by the subject in her diary.
Time frame: Day 1 to Day 57
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 10 Dec 2024.
- 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.
Elisabeth GUITTON-OUDET, Dr principal investigator
SpinControl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
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 24 inclusion and 0 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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Biological efficacy assessed by the analysis of proteins expression related to aging. (time frame: Day 57). The study lists 3 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 10 Dec 2024.