Anti-agingNCT05895591
Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream
A study testing Anti-aging cosmetic care product in people with Anti-aging, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
The aim of the study is to determine the efficacy of the investigational product "Cream " : on skin network after 56 days of daily application on biological parameters linked to cellular communication involved in senescence on sebum composition (metagenomics and metabolomics analysis) Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anti-aging
- What is being tested?
- Anti-aging cosmetic care product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2021to 14 Dec 2021
- Phase
- Interventional
- 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 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- sensitive skin (declaratory judgment)
- face skin type: combination to normal skin
- presenting wrinkles and/or finelines on the whole face
- displaying saggy skin on the face (loss of firmness)
- presenting a lack of skin radiance, dull complexion and an inhomogeneous skin on the face
Who cannot join
- Related to the treatment/product:
- having had any surgery, chemical or significant invasive dermo-treatment on the experimental area considered by the Investigator liable to interfere with the study data
- having undergone techniques with aesthetic aim on study areas (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp etc.) or having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin etc.)
- having applied products with an anti-aging action (Retinoic acid, retinol, retinaldehyde, A.H.A. etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study to Assess Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream in Women After 2 Months of Daily Use, Under Dermatological Control
The aim of the study is to determine the efficacy of the investigational product "Cream " :
- on skin network after 56 days of daily application
- on biological parameters linked to cellular communication involved in senescence
- on sebum composition (metagenomics and metabolomics analysis)
Read the detailed description
This study will be conducted as a monocentric, randomized (for side of product application on forearms), open trial.
4 visits are planned:
- Visit 1 - Inclusion (D1)
- Visit 2 - Follow-up visit (D29), a window of +72 hours is allowed for this evaluation,
- Visit 3 - End of the application period (D57), a window of +72 hours is allowed for this evaluation
- Visit 4 - Follow-up visit (D7 post-biopsies +/- 24h)
For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum.
The study duration for each subject will be 67 days maximum.
- Conditions
- Anti-aging
- 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
- frequency of application: Once a day (in the morning)
- modalities of application: Apply the cream on face (according to normal conditions of use) and on treated forearm, massage until complete penetration
- area: The whole face, neck, neckline and one randomized forearm (external photo-exposed area) the other forearm is untreated
- duration of investigational product application: 56 days (a window of + 72 hours is allowed)
- quantity: 2 pressures of product for the whole face, neck and neckline and 1 pressure of product for the treated forearm
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Experimental | all subjects will apply the study product Receives: Other: Anti-aging cosmetic care product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of skin network (SRa parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)
SRa: Average roughness (mm). Average variations in amplitude of the relief integrated into the studied surface.
Measured: Change from baseline to Day 57
Assessment of skin network (SRq parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)
SRq: Roughness with regards to the average quadratic plan (mm).
Measured: Change from baseline to Day 57
Assessment of sebum metabolites' composition
Metabolomics analysis from sebum samples using mass spectrometry
Measured: Change from baseline to Day 57
Assessment of skin metagenomic composition
Metagenomics analysis from sebum samples using targeted DNA sequencing
Measured: Change from baseline to Day 57
Expression of cellular communication markers linked to senescence
RNA expression from skin biopsies using RNA-Seq
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start12 Oct 2021
- Primary completion7 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-agingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895591
- Sponsor's protocol ID
- RV4981A20210184
- Status last verified
- Apr 2023
- First submitted
- 19 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Assess Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream in Women After 2 Months of Daily Use, Under Dermatological Control
- ClinicalTrials.gov ID
- NCT05895591
- Acronym / sponsor ID
- RV4981A20210184
- Conditions
- Anti-aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 8 Jun 2023 (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 aim of the study is to determine the efficacy of the investigational product "Cream " :
- on skin network after 56 days of daily application
- on biological parameters linked to cellular communication involved in senescence
- on sebum composition (metagenomics and metabolomics analysis)
Detailed description
This study will be conducted as a monocentric, randomized (for side of product application on forearms), open trial.
4 visits are planned:
- Visit 1 - Inclusion (D1)
- Visit 2 - Follow-up visit (D29), a window of +72 hours is allowed for this evaluation,
- Visit 3 - End of the application period (D57), a window of +72 hours is allowed for this evaluation
- Visit 4 - Follow-up visit (D7 post-biopsies +/- 24h)
For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum.
The study duration for each subject will be 67 days maximum.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Group | Experimental | Other: Anti-aging cosmetic care productall subjects will apply the study product |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- sensitive skin (declaratory judgment)
- face skin type: combination to normal skin
- presenting wrinkles and/or finelines on the whole face
- displaying saggy skin on the face (loss of firmness)
- presenting a lack of skin radiance, dull complexion and an inhomogeneous skin on the face
Key exclusion criteria (4 listed)
- having had any surgery, chemical or significant invasive dermo-treatment on the experimental area considered by the Investigator liable to interfere with the study data
- having undergone techniques with aesthetic aim on study areas (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp etc.) or having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin etc.)
- having applied products with an anti-aging action (Retinoic acid, retinol, retinaldehyde, A.H.A. etc.)
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 product* frequency of application: Once a day (in the morning) * modalities of application: Apply the cream on face (according to normal conditions of use) and on treated forearm, massage until complete penetration * area: The whole face, neck, neckline and one randomized forearm (external photo-exposed area) the other forearm is untreated * duration of investigational product application: 56 days (a window of + 72 hours is allowed) * quantity: 2 pressures of product for the whole face, neck and neckline and 1 pressure of product for the treated forearm | Other | Treated Group |
Primary outcome
Assessment of skin network (SRa parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)
Time frame: Change from baseline to Day 57
SRa: Average roughness (mm). Average variations in amplitude of the relief integrated into the studied surface.
Assessment of skin network (SRq parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)
Time frame: Change from baseline to Day 57
SRq: Roughness with regards to the average quadratic plan (mm).
Assessment of sebum metabolites' composition
Time frame: Change from baseline to Day 57
Metabolomics analysis from sebum samples using mass spectrometry
Assessment of skin metagenomic composition
Time frame: Change from baseline to Day 57
Metagenomics analysis from sebum samples using targeted DNA sequencing
Expression of cellular communication markers linked to senescence
Time frame: Day 57
RNA expression from skin biopsies using RNA-Seq
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 8 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-aging cosmetic care product in people with Anti-aging, 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 5 inclusion and 4 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 8 Jun 2023. 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?
Assessment of skin network (SRa parameter) by Fringe projection on silicone rubber replica (on one randomized forearm) (time frame: Change from baseline to Day 57). The study lists 5 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 8 Jun 2023.