In-use Tolerance and Efficacy Study Under Dermatological and Ophthalmological Controls - Face Cream, RV4983A - LA3365

NCT07208227 | Completed

• 1 other identifier: RV4983A20210135
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Tolerance and efficacy study of an anti aging cream on 44 subjects aged between 45 and 65 years, with sensitive skin and deep wrinkles. This study is conducted as a national, monocentric, non-randomized open trial. Planning of the visits:

• Visit 1: Inclusion (Day 1)
• Visit 2: Intermediate visit (Day 29), a window of +48 hours is allowed
• Visit 3: End of study (Day 57), a window of +72 hours is allowed The maximum duration of participation for a subject is 60 days.

Conditions

Healthy; Sensitive Skin; Deep Wrinkles

Keywords

open trial; antiaging cosmetic cream

Outcome Measures

Primary Outcomes (1)

• Global tolerance assessment

  Global tolerance is assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product. Global assessment of the dermatological and ophthalmological tolerance is done by the investigator. This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad.

  At the end of the study, after Last Patient Out, (after Day 57)

Secondary Outcomes (11)

• Ra parameter to evaluate smoothing/anti-wrinkle effect

  Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

• Rz parameter to evaluate smoothing/anti-wrinkle effect

  Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

• Rt parameter to evaluate smoothing/anti-wrinkle effect

  Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

• Clinical scoring of the visibility of crow's feet wrinkles

  Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

• Clinical scoring of the Smoothness of the skin

  Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

Study Arms (1)

Test group

Other: Face Cream RV4983A LA3365

Interventions

Face Cream RV4983A LA3365 OTHER

Cosmetic face cream product applied once a day on face, neck and neckline.

Test group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non-inclusion criteria specific to the study. They will be definitely included in the study after a specific interview and a clinical examination.

You may qualify if:

• Criteria related to the population:
• female
• aged between 45 and 65 years included
• phototype: I to III
• skin type: oily, combination, normal, dry, very dry
• % of subjects with sensitive skin on the face
• % of subjects with deep wrinkles on the face
• % of subjects with sagging skin on the face
• % of subjects with dull and uneven complexion
• 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
• a maximum of 20% of subjects being lens wearers will be included in the study

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Eurofins Dermscan Poland Sp. z o. o

Gdansk, Poland, 80288, Poland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 6, 2025
• Study Start: October 27, 2021
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

PL (1)