Ignite Creation Date:
2025-12-24 @ 12:33 PM
Ignite Modification Date:
2025-12-30 @ 5:29 AM
Study NCT ID:
NCT05765461
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2023-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lipikar Baume AP+M on Quality of Life and Pain of Adults With Dryness or Severe Xerosis
Sponsor:
Cosmetique Active International
Organization:
Study Overview
Official Title:
Effect of Lipikar Baume AP+M on Quality of Life and Pain Related to Atopic Dermatitis and Other Skin Diseases With Dryness or Severe Xerosis on Adults
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This study aims at evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. Patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. They may be prescribed a corticosteroid upon decision of the dermatologist.
Detailed Description:
The general approach of the statistical methodology is the following:
* The qualitative variables are described with number and percent of each level.
* The quantitative variables are described with mean and standard deviation.
* All statistical hypotheses are performed at the 5% significance level using 2-sided tests.
* Given the large sample size, no normality assessment will be done.
* Mean reduction rate for quantitative variables is calculated as (mean v0 - mean v1)/mean v0)\*100.
* Due to the high number of zeros at inclusion in the self-assessment quantitative criteria, analyses will concern only patient with an intensity above 0 at inclusion or at final visit.
* Response rate for qualitative variables is calculated as the percent of patients with at least on level decrease between the two visits.
* Response rate for satisfaction is the percent of patients declaring being Satisfied or Very satisfied.
* Response rate for tolerance is the percent of patients declaring the tolerance High or Excellent.
* The qualitative variables are described with number and percent of each level.
* The quantitative variables are described with mean and standard deviation.
* All statistical hypotheses are performed at the 5% significance level using 2-sided tests.
* Given the large sample size, no normality assessment will be done.
* Mean reduction rate for quantitative variables is calculated as (mean v0 - mean v1)/mean v0)\*100.
* Due to the high number of zeros at inclusion in the self-assessment quantitative criteria, analyses will concern only patient with an intensity above 0 at inclusion or at final visit.
* Response rate for qualitative variables is calculated as the percent of patients with at least on level decrease between the two visits.
* Response rate for satisfaction is the percent of patients declaring being Satisfied or Very satisfied.
* Response rate for tolerance is the percent of patients declaring the tolerance High or Excellent.
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?: