Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT05171556
Brief 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.
Study:
NCT05171556
Study Brief:
Protocol Section:
NCT05171556