Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 10:19 AM
Study NCT ID:
NCT05767333
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2023-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cicaplast in Subjects With Skin Irritation
Sponsor:
Cosmetique Active International
Organization:
Study Overview
Official Title:
Evaluation of Cicaplast in Subjects With Skin Irritation for 21 Days
Status:
COMPLETED
Status Verified Date:
2023-03
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 open, before/after, multicentric study is to assess the effect and tolerance of Cicaplast Baume B5 in patients having a skin irritation (irritative and cracked dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. Patients are asked to apply the product at least twice a day until complete recovery (maximum 21 days).
Detailed Description:
Dermscan has implemented a quality management system which has been certified by the International Standards Organization (ISO 9001: 2015). This quality assurance system includes appropriate Good Clinical Practices (GCP) and regulation requirements. The proofreader is not involved in the audited study. A certificate of quality inspection signed by the person who checked the report is enclosed in each study.
Statistical method
Regarding the descriptive analysis, the quantitative data is summarized using the following statistics by time point:
* Number of values
* Mean
* Median
* Standard deviation (SD)
* Minimum value
* Maximum value.
Are summarized in frequency (N) and percentage (%) by time point:
* the Investigator's Global Assessment (IGA) score assessed by the investigator using a 6-point scale
* the soothing effect assessed by the subject using a 4-point scale for the parameters pain and pruritus
* each global tolerance score assessed by the investigator and by the subject using a 4-point scale.
The score of anti-irritating effect (SCOre de REparation de l'EPIderme= SCOREPI) is summarized using statistics for quantitative variables at each time point.
The local signs of irritated area assessed using a 4-point scale (erythema, desquamation, pigmentation, cracks, oedema) are summarized in frequency (N) and percentage (%) and by time point and by parameter.
Statistical method
Regarding the descriptive analysis, the quantitative data is summarized using the following statistics by time point:
* Number of values
* Mean
* Median
* Standard deviation (SD)
* Minimum value
* Maximum value.
Are summarized in frequency (N) and percentage (%) by time point:
* the Investigator's Global Assessment (IGA) score assessed by the investigator using a 6-point scale
* the soothing effect assessed by the subject using a 4-point scale for the parameters pain and pruritus
* each global tolerance score assessed by the investigator and by the subject using a 4-point scale.
The score of anti-irritating effect (SCOre de REparation de l'EPIderme= SCOREPI) is summarized using statistics for quantitative variables at each time point.
The local signs of irritated area assessed using a 4-point scale (erythema, desquamation, pigmentation, cracks, oedema) are summarized in frequency (N) and percentage (%) and by time point and by parameter.
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?: