In-use Tolerance and Efficacy Study Under Dermatological Control of an Anti-aging Cream (Split Face) Post Facial Superficial Rejuvenation Procedures, After re Epidermization

NCT06942403 | Completed

• 1 other identifier: RV4983A20230413
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

  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

  At the end of study (Day 176)

Secondary Outcomes (11)

• 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

  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

  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

  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

  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.

Study Arms (2)

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

Interventions

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)

Associated product 2 MORNING : RV5000A OTHER

Applied in the mornings from Day 8 to Day 95 or Day 176\* \* for subjects post injections

Control group (hemiface); Treated group (hemiface)

Test product : RV4983A OTHER

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

Treated group (hemiface)

Associated product 2 EVENING: RV5000A OTHER

Applied in the evenings from Day 8 to Day 95 or Day 176\* \* for subjects post injections

Control group (hemiface)

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• subjects after peeling (30 or 50% glycolic acid);
• subjects after laser CO2

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Dermscan Poland

Gdansk, Poland, 80288, Poland

Location

Related Publications (1)

• 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.

  PMID: 41312593 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: According to randomization, each subject will have a treated half face and a control half face.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 24, 2025
• Study Start: September 27, 2023
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

PL (1)