Effect of Lipikar Baume AP+M on Quality of Life and Pain of Adults With Dryness or Severe Xerosis

Study Overview
=================
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.

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

Conditions
-----------------
Atopic Dermatitis, Skin Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • atopic dermatitis or other skin disease with dryness or severe xerosis Exclusion Criteria: • patients not suffering from atopic dermatitis or other skin disease with dryness or severe xerosis

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the intensity of skin disease | The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe) | from baseline to Day56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the intensity of skin dryness | The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe) | from baseline to Day56 | 
| evolution of the inflammatory lesions surface | The dermatologist evaluates the inflammatory lesions surface with the following scale: none <10% [10%;30%[ >30% | from baseline to Day56 | 
| change in the intensity of pruritus | The dermatologist evaluates the intensity of pruritus on a 5-point scale (from absent to very severe) | from baseline to Day56 | 
| change in the quality of sleep | The dermatologist evaluates the intensity of pruritus on a 5-point scale (from unaffected to very severely affected) | from baseline to Day56 | 
| change in the daily discomfort | The dermatologist evaluates the intensity of the daily discomfort on a 5-point scale (from absent to very severe) | from baseline to Day56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atopic dermatitis, severe xerosis, quality of life, dryness