Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 5:19 PM
Study NCT ID:
NCT05171556
Status:
COMPLETED
Last Update Posted:
2021-12-29
First Post:
2021-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Balm)
Sponsor:
Pierre Fabre Dermo Cosmetique
Organization:
Study Overview
Official Title:
IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: