Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 5:15 AM
Study NCT ID:
NCT05471934
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2022-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satisfaction Survey - Cicaplast Mains
Sponsor:
Cosmetique Active International
Organization:
Study Overview
Official Title:
Satisfaction Survey - Cicaplast Mains
Status:
COMPLETED
Status Verified Date:
2022-07
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 participants presenting with hand problems and meeting the inclusion criteria are asked to apply the study product for one month. They are evaluated before and after treatment.
Detailed Description:
The international, open, observational survey is conducted in 3 different countries.
Regarding the statistical analysis, the global satisfaction is described in 5 classes and in 2 classes "Satisfied + Very satisfied" vs. "Neither satisfied nor dissatisfied + Not so satisfied + Not at all satisfied". The 95% Confidence Interval (CI) of the percent of "Satisfied + Very satisfied" is also given.
On patients who already used cream at the inclusion, the following analyses are performed:
* Cross-tabulation between both visits,
* Test of the evolution between both visits using a special procedure for ordinal data with repeated measures,
* Description of a summary variable in 3 classes (Improved / No change / Worsened).
For the analysis of the hands problems, each sign is described at the inclusion and at the evaluation visit. The difference Evaluation-Inclusion is also given. The evolution of the sign is performed by a Wilcoxon test for matched samples.
Regarding the statistical analysis, the global satisfaction is described in 5 classes and in 2 classes "Satisfied + Very satisfied" vs. "Neither satisfied nor dissatisfied + Not so satisfied + Not at all satisfied". The 95% Confidence Interval (CI) of the percent of "Satisfied + Very satisfied" is also given.
On patients who already used cream at the inclusion, the following analyses are performed:
* Cross-tabulation between both visits,
* Test of the evolution between both visits using a special procedure for ordinal data with repeated measures,
* Description of a summary variable in 3 classes (Improved / No change / Worsened).
For the analysis of the hands problems, each sign is described at the inclusion and at the evaluation visit. The difference Evaluation-Inclusion is also given. The evolution of the sign is performed by a Wilcoxon test for matched samples.
Study Oversight
Has Oversight DMC:
None
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?: