In-use Tolerance and Efficacy Study Under Dermatological Control of an Anti-aging Cream (Split Face) Post Facial Superficial Rejuvenation Procedures, After re Epidermization
Status
Conditions
Treatments
Details and patient eligibility
About
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:
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Visit 1: Inclusion (Day 1) - The subjects undergo their procedure (peeling, LASER or injections).
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Home application of the associated product 1 period: Day 1 to Day 7
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Visit 2: intermediate visit (Day 8) subjects received investigational product and associated product 2;
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Visit 3, 4, and 5: Intermediate visit (Day 37, Day 66 and Day 95*),
*the final visit for the subjects post peeling and LASER
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Visit 6**: End of study (Day 176), ** for subjects post injections
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
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
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
66 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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