In-use Tolerance and Efficacy Study Under Dermatological... | NCT06942403

NCT06942403

Status Module

Description Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Associated product 1 : RV2666C	Other	Applied twice a day minimum during 7 days (from Day 1 to Day 7)	Control group (hemiface) Treated group (hemiface)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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

Secondary Outcomes

Measure	Description	Time Frame
Smoothing/anti-wrinkle effect by instrumental measurements using 3D PRIMOS-LITE®		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

Eligibility Module

Eligibility 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