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.
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.
Study Type
OBSERVATIONAL
Enrollment
4,631
Dermatology practices
Zagreb, Croatia
Dermatology practices
Berlin, Germany
Dermatology practices
Lisbon, Portugal
Dermatology practices
Pretoria, South Africa
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)
Time frame: from baseline to Day56
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)
Time frame: 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%
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: from baseline to Day56
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Dermatology practices
Taipei, Taiwan
Dermatology practices
Bangkok, Thailand
Dermatology practices
Hanoi, Vietnam