NCT05171556

IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Balm)

IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the dermatological and ophthalmological tolerance of the investigational product Baume visage / Face balm RV4942A - RY1985 after 21 days of twice daily use on the study areas, under normal conditions of use. The aim of this study is also to: * evaluate the cutaneous sensitivity by a stinging test at D1 T0 and D22. * evaluate the cutaneous sensitivity by a sensitive scale at D1 T0, D1 Timm\*, D8 and D22. * evaluate the soothing efficacy by an efficacy questionnaire at D1 Timm\*, D8 and D22. * evaluate the cosmetic acceptability by a questionnaire at D22. This study is conducted as a national, monocentric, non-randomized open trial. The 33 subjects in this study (31 subjects on D22) present hypersensitive, reactive and intolerant skin on face. They are stinger subjects, with a dry to very dry skin. Timm\*: 10 to 30 minutes after first application

Detailed description

his study is a national, monocentric, non-randomized open trial, conducted in adults presenting hypersensitive, reactive and intolerant skin on the face, with a dry to very dry skin. The study includes 3 visits, including subjects' selection: * V1: Baseline inclusion * V2: 1 week, intermediate visit * V3: 3 weeks, study end The maximal study duration is 25 days. The evaluation is at 3 times: D1 baseline, D8 at 1 week and D22 at 3 weeks of application of RV4942A - RY1985 with comparison of each time versus baseline. There are twice-daily applications (morning and evening) of the test product on the face.

Conditions

• Hypersensitive
• Reactive and Intolerant Skin
• Redness-prone Skin
• Stinger Subjects

Interventions

Type	Name	Description
OTHER	Cosmetic product	RV4942A is a face balm product

Timeline

• Start date: 2021-04-20
• Primary completion: 2021-05-11
• Completion: 2021-05-11
• First posted: 2021-12-29
• Last updated: 2021-12-29

Locations

1 site across 1 country: China