HealthyNCT06942403
In-use Tolerance and Efficacy Study Under Dermatological Control of an Anti-aging Cream (Split Face) Post Facial Superficial Rejuvenation Procedures, After re Epidermization
A study testing Associated product 1 : RV2666C, Associated product 2 MORNING : RV5000A and Test product : RV4983A in people with Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.
Trial summary
The aim of this study is to assess the dermatological tolerance of the investigational product "Crème visage Product code: RV4983A / Formula code: LA3365" after 95 days for subjects post peeling and LASER and 176 days for subjects post injections of once daily use at the evening on the half face, under normal… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Associated product 1 : RV2666C, Associated product 2 MORNING : RV5000A and Test product : RV4983A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePoland
- Study dates
- 27 Sep 2023to 26 Mar 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Criteria related to the population:
- female and male
- aged between 35 and 70 years included
- phototype: I to IV
- all skin types
- subjects must be registered with health social security or health social insurance
Show all 43Show fewer
- having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
- certifying the truth of the personal information declared to the Investigator able to understand the language used in the investigation centre and the information given
- able to comply with the protocol and follow protocol's constraints and specific requirements
- cooperative subject, aware of the necessity and duration of controls so that perfect adhesion to the protocol established by the clinical trial centre could be expected (able to comply with the protocol and follow protocol's constraints and specific requirements)
- a maximum of 20% of subjects being lens wearers will be included in the study
- Criteria related to the skin condition:
- Subjects having performed superficial rejuvenation procedures on the face including the crow's foot area:
- 20 subjects after peeling (30 or 50% glycolic acid);
- 20 subjects after laser CO2
- 20 subjects after injections of hyaluronic acid or mix containing hyaluronic acid All procedures must remain superficial and aiming an anti-aging effect. Instrumental technics will be on the crow's foot so all procedures must be performed on the face including on this area.
- Criteria related to subject's health:
- Considered "healthy subject" by the Investigator
- Women of childbearing potential committing themselves to use effective contraceptive method throughout the study and for at least 3 months before the inclusion visit (with no change during this period)
- Non-Inclusion Criteria:
- Criteria related to the population:
- having participated in another clinical trial within the week before the inclusion visit and for a longer period if required in the Investigator's opinion
- taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
- breastfeeding, pregnant (for the women of childbearing potential)
- deprived of freedom by administrative or legal decision or under guardianship - not able to be contacted in case of emergency
- admitted in a sanitary or social facilities
- planning an hospitalization during the study
- belonging to the staff of the investigation centre
- Criteria related to the skin condition
- having a dermatological condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- having personal medical history liable to interfere with the study data for the subject or incompatible with the study requirements (except if this population is required by the Sponsor i.e atopic dermatitis)
- having history of abnormal reactions from exposure to sunlight
- having history of hypersensitivity or intolerance to any cosmetic product
- Criteria related to treatments
- Topical or systemic treatment liable to interfere with the study data according to investigator's assessment
- having used a self-tanning product during the previous month
- having received, on the study areas, artificial UV exposure or excessive exposure to natural sunlight within the month before the inclusion visit (at Investigator's opinion)
- Criteria related to investigational product application areas:
- 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, before the inclusion visit or foreseeing it for the duration of the study (except if the treatment is required by the Sponsor)
- having applied a skincare or make up product on the study areas the day of the inclusion visit (except the usual cleanser)
- having received, on the study areas, artificial UV exposure or excessive exposure to natural sunlight within the 2 weeks before the inclusion visit
- Criteria related to the COVID-19:
- subject who does not meet the Ministry of Health guidelines for Covid-19 at the time of the visit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the dermatological tolerance of the investigational product "Crème visage Product code: RV4983A / Formula code: LA3365" after 95 days for subjects post peeling and LASER and 176 days for subjects post injections of once daily use at the evening on the half face, under normal conditions of use, on 66 subjects.
This study will be conducted as a national, monocentric, open trial.
Read more
Planning of the visits:
- Visit 1: Inclusion (Day 1) - The subjects undergo their procedure (peeling, LASER or injections).
- Home application of the associated product 1 period: Day 1 to Day 7
- Visit 2: intermediate visit (Day 8) subjects received investigational product and associated product 2;
- Visit 3, 4, and 5: Intermediate visit (Day 37, Day 66 and Day 95*), *the final visit for the subjects post peeling and LASER
- Visit 6: End of study (Day 176), for subjects post injections
- Conditions
- Healthy
- Being tested
- Associated product 1 : RV2666C, Associated product 2 MORNING : RV5000A, Test product : RV4983A, Associated product 2 EVENING: RV5000A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Associated product 1 : RV2666COther
Applied twice a day minimum during 7 days (from Day 1 to Day 7)
Associated product 2 MORNING : RV5000AOther
Applied in the mornings from Day 8 to Day 95 or Day 176*
- for subjects post injections
Test product : RV4983AOther
Applied once a day, at the evening. Avoid contact with eyes. If sensations of discomfort appear, allow more time between applications.
- From Day 8 to Day 95 (87 days) for post LASER and post peeling subjects
- From Day 8 to Day 176 (169 days) for post-injections subjects
Associated product 2 EVENING: RV5000AOther
Applied in the evenings from Day 8 to Day 95 or Day 176*
- for subjects post injections
| Study group | Role | What they receive |
|---|---|---|
| Treated group (hemiface) | Experimental | Not described Receives: Other: Associated product 1 : RV2666C; Other: Associated product 2 MORNING : RV5000A; Other: Test product : RV4983A |
| Control group (hemiface) | Other | Not described Receives: Other: Associated product 1 : RV2666C; Other: Associated product 2 MORNING : RV5000A; Other: Associated product 2 EVENING: RV5000A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of dermatological physical signs by the investigator
The following signs are recorded by the investigator : erythema, oedema, desquamation, skin dry, vesicle, papule, any other sign observed.
For each sign:
- Intensity has to be reported by using the following scale: 0 none, 1 very mild, 2 mild, 3 moderate, 4 severe
- For papules, vesicles, an estimation of the quantity is required instead of an intensity
- Location, duration and frequency are also reported.
Each time a sign occurs (either new sign or worsened compared to the baseline evaluation i.e evaluation at Day 8), a reaction is recorded in the CRF. Other signs present at the inclusion visit without any change in terms of severity are recorded as well in the CRF but not considered as reactions.
Measured: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Assessment of dermatological functional signs by the subject
The following signs are recorded by the subject : burning sensation, sensation of warmth, itching, skin tightness, stinging, any other sign observed.
For each sign:
- Intensity has to be reported by using the following scale: 0 none, 1 very mild, 2 mild, 3 moderate, 4 severe
- Location, duration and frequency are also reported. Each time a sign occurs (either new sign or worsened compared to the baseline evaluation i.e evaluation at Day 8), a reaction is recorded in the CRF. Other signs present at the inclusion visit without any change in terms of severity are recorded as well in the CRF but not considered as reactions.
Measured: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit
Recording of reactions
All the reactions observed by the Investigator and reported by the subject are recorded.
The following information are recorded:
- Subject characteristics
- Details about product
- Description of the reaction
- Significant medical history
- Concomitant events
- Outcome and actions taken
- Relationship to the product (investigational product) : causality assessment The Investigator should assess the causality according to the three levels of causality : Very likely / Likely ; Not clearly attributable / Unlikely ; Excluded
Measured: During the entire course of the study (from Day 1 to Day 95 or Day 176)
Global tolerance assessment by the investigator
Global tolerance will be assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product.
This assessment allows for attribution of one of the 5 levels below:
- Excellent
- Very good
- Good
- Moderate
- Bad
Measured: At the end of study (Day 176)
Secondary outcomes (11)
Smoothing/anti-wrinkle effect by instrumental measurements using 3D PRIMOS-LITE®
Measured: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Crow's feet wrinkles (according to Bazin scale) by the investigator
Measured: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Smoothness of the skin by the investigator
On a 11-points scale (0=wrinkled skin, 10=smooth skin)
Measured: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Firmness of the skin by the investigator
On a 11-points scale (0=lack of firmness, 10=firm skin)
Measured: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Skin plumpness by the investigator
On a 11-points scale (0=lack of plumpness, 10=plump skin)
Measured: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Radiance of the complexion assessed by clinical scoring on pictures by technician
The complexion grading is performed on photographs (with Nikon®, in standard light) by a technician On a 11-points scale (0=Dull complexion, 10=radiant complexion)
Measured: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Homogenity of skin tone assessed by clinical scoring on pictures by technician
The complexion grading is performed on photographs (with Nikon®, in standard light) by a technician On a 11-points scale (0=Not even at all, 10=very even skin texture)
Measured: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Skin texture assessed by clinical scoring on pictures by technician
The complexion grading is performed on photographs (with Nikon®, in standard light) by a technician On a 11-points scale (0=Coarse, 10=Fine)
Measured: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Visual expected effect
The device used is the VISIA® from CANFIELD® imaging systems. The VISIA allows taking pictures with multiple lighting modes and a very rapid capture of images. One photograph of the full face, each profile and crow feet is taken under multi-spectral imaging and analysis (normal light) allows capturing visual information
Measured: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Cosmetic Acceptability evaluation by subjects
A subjective evaluation questionnaire, prepared by the Sponsor, is filled in by the subjects at the end of the study to subjectively evaluate the properties, the efficacy, the tolerance and the future use of the studied product.
Measured: At the end of the study (Day 95 for post LASER and post peeling subjects, Day 176 for post injections subjects)
Subject's compliance regarding the test product recorded in their daily log checked by the investigator
- Subjects are asked to keep a diary for recording of their daily applications details. This diary is returned by the subject at each visit to be checked by the investigator
- A compliant subject will be defined as a subject who did apply the investigational product sufficiently to not interfere with the study data according to the Investigator's opinion and the modalities of use of the product.
- List of non-compliant subjects will be displayed in the study report.
Measured: During the entire course of the study (from Day 1 to Day 95 or Day 176)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start27 Sep 2023
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- According to randomization, each subject will have a treated half face and a control half face.
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT06942403
- Sponsor's protocol ID
- RV4983A20230413
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monteil C, Barreto-Campos V, Lain E, Guillou E, Doat G, Nocera T. Enhancing Facial Rejuvenation Outcomes With a Novel Retinaldehyde-Based Cream: A Comparative Randomized Intra-Individual Study. J Cosmet Dermatol. 2025 Dec;24(12):e70555. doi: 10.1111/jocd.70555.
PubMed 41312593
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-use Tolerance and Efficacy Study Under Dermatological Control of an Anti-aging Cream (Split Face) Post Facial Superficial Rejuvenation Procedures, After re Epidermization
- ClinicalTrials.gov ID
- NCT06942403
- Acronym / sponsor ID
- RV4983A20230413
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 24 Apr 2025 (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 this study is to assess the dermatological tolerance of the investigational product "Crème visage Product code: RV4983A / Formula code: LA3365" after 95 days for subjects post peeling and LASER and 176 days for subjects post injections of once daily use at the evening on the half face, under normal conditions of use, on 66 subjects.
This study will be conducted as a national, monocentric, open trial.
Planning of the visits:
- Visit 1: Inclusion (Day 1) - The subjects undergo their procedure (peeling, LASER or injections).
- Home application of the associated product 1 period: Day 1 to Day 7
- Visit 2: intermediate visit (Day 8) subjects received investigational product and associated product 2;
- Visit 3, 4, and 5: Intermediate visit (Day 37, Day 66 and Day 95*), *the final visit for the subjects post peeling and LASER
- Visit 6: End of study (Day 176), for subjects post injections
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- According to randomization, each subject will have a treated half face and a control half face.
| Arm | Type | Receives |
|---|---|---|
| Treated group (hemiface) | Experimental | Other: Associated product 1 : RV2666C, Other: Associated product 2 MORNING : RV5000A, Other: Test product : RV4983A |
| Control group (hemiface) | Other | Other: Associated product 1 : RV2666C, Other: Associated product 2 MORNING : RV5000A, Other: Associated product 2 EVENING: RV5000A |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- female and male
- aged between 35 and 70 years included
- phototype: I to IV
- all skin types
- subjects must be registered with health social security or health social insurance
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 |
|---|---|---|
| Associated product 1 : RV2666CApplied twice a day minimum during 7 days (from Day 1 to Day 7) | Other | Control group (hemiface), Treated group (hemiface) |
| Associated product 2 MORNING : RV5000AApplied in the mornings from Day 8 to Day 95 or Day 176* * for subjects post injections | Other | Control group (hemiface), Treated group (hemiface) |
| Test product : RV4983AApplied once a day, at the evening. Avoid contact with eyes. If sensations of discomfort appear, allow more time between applications. * From Day 8 to Day 95 (87 days) for post LASER and post peeling subjects * From Day 8 to Day 176 (169 days) for post-injections subjects | Other | Treated group (hemiface) |
| Associated product 2 EVENING: RV5000AApplied in the evenings from Day 8 to Day 95 or Day 176* * for subjects post injections | Other | Control group (hemiface) |
Primary outcome
Assessment of dermatological physical signs by the investigator
Time frame: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
The following signs are recorded by the investigator : erythema, oedema, desquamation, skin dry, vesicle, papule, any other sign observed. For each sign: * Intensity has to be reported by using the following scale: 0 none, 1 very mild, 2 mild, 3 moderate, 4 severe * For papules, vesicles, an estimation of the quantity is required instead of an intensity * Location, duration and frequency are also reported. Each time a sign occurs (either new sign or worsened compared to the baseline evaluation i.e evaluation at Day 8), a reaction is recorded in the CRF. Other signs present at the inclusion visit without any change in terms of severity are recorded as well in the CRF but not considered as reactions.
Assessment of dermatological functional signs by the subject
Time frame: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit
The following signs are recorded by the subject : burning sensation, sensation of warmth, itching, skin tightness, stinging, any other sign observed. For each sign: * Intensity has to be reported by using the following scale: 0 none, 1 very mild, 2 mild, 3 moderate, 4 severe * Location, duration and frequency are also reported. Each time a sign occurs (either new sign or worsened compared to the baseline evaluation i.e evaluation at Day 8), a reaction is recorded in the CRF. Other signs present at the inclusion visit without any change in terms of severity are recorded as well in the CRF but not considered as reactions.
Recording of reactions
Time frame: During the entire course of the study (from Day 1 to Day 95 or Day 176)
All the reactions observed by the Investigator and reported by the subject are recorded. The following information are recorded: * Subject characteristics * Details about product * Description of the reaction * Significant medical history * Concomitant events * Outcome and actions taken * Relationship to the product (investigational product) : causality assessment The Investigator should assess the causality according to the three levels of causality : Very likely / Likely ; Not clearly attributable / Unlikely ; Excluded
Global tolerance assessment by the investigator
Time frame: At the end of study (Day 176)
Global tolerance will be assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product. This assessment allows for attribution of one of the 5 levels below: * Excellent * Very good * Good * Moderate * Bad
11 secondary outcomes
Smoothing/anti-wrinkle effect by instrumental measurements using 3D PRIMOS-LITE®
Time frame: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Crow's feet wrinkles (according to Bazin scale) by the investigator
Time frame: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Smoothness of the skin by the investigator
Time frame: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Firmness of the skin by the investigator
Time frame: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Skin plumpness by the investigator
Time frame: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Radiance of the complexion assessed by clinical scoring on pictures by technician
Time frame: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Homogenity of skin tone assessed by clinical scoring on pictures by technician
Time frame: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Skin texture assessed by clinical scoring on pictures by technician
Time frame: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Visual expected effect
Time frame: At the Visit 2 (Day 8, before investigational product application) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.
Cosmetic Acceptability evaluation by subjects
Time frame: At the end of the study (Day 95 for post LASER and post peeling subjects, Day 176 for post injections subjects)
Subject's compliance regarding the test product recorded in their daily log checked by the investigator
Time frame: During the entire course of the study (from Day 1 to Day 95 or Day 176)
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 24 Apr 2025.
- Derived from this study: PubMed 41312593Monteil C, Barreto-Campos V, Lain E, Guillou E, Doat G, Nocera T. Enhancing Facial Rejuvenation Outcomes With a Novel Retinaldehyde-Based Cream: A Comparative Randomized Intra-Individual Study. J Cosmet Dermatol. 2025 Dec;24(12):e70555. doi: 10.1111/jocd.70555.
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
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 Associated product 1 : RV2666C, Associated product 2 MORNING : RV5000A and Test product : RV4983A in people with Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.
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 43 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 24 Apr 2025. 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 Poland. 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 dermatological physical signs by the investigator (time frame: At the Visit 2 (Day 8, before and immediately after investigational product application: 10 to 30 minutes) and at the Day 37, Day 66, Day 95 and Day 176 (for post-injections subjects) visit.). 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?
On the ClinicalTrials.gov record for NCT06942403, which also lists 1 linked publication.
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 24 Apr 2025.