Effect of Lipikar Baume AP+M on Quality of Life and Pain of Adults With Dryness or Severe Xerosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The general approach of the statistical methodology is the following:
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The qualitative variables are described with number and percent of each level.
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The quantitative variables are described with mean and standard deviation.
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All statistical hypotheses are performed at the 5% significance level using 2-sided tests.
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Given the large sample size, no normality assessment will be done.
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Mean reduction rate for quantitative variables is calculated as (mean v0 - mean v1)/mean v0)*100.
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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.
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Response rate for qualitative variables is calculated as the percent of patients with at least on level decrease between the two visits.
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Response rate for satisfaction is the percent of patients declaring being Satisfied or Very satisfied.
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Response rate for tolerance is the percent of patients declaring the tolerance High or Excellent.
Study Design
Outcome Measures
Primary Outcome Measures
- change in the intensity of skin disease [from baseline to Day56]
The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)
Secondary Outcome Measures
- change in the intensity of skin dryness [from baseline to Day56]
The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)
- evolution of the inflammatory lesions surface [from baseline to Day56]
The dermatologist evaluates the inflammatory lesions surface with the following scale: none <10% [10%;30%[ >30%
- change in the intensity of pruritus [from baseline to Day56]
The dermatologist evaluates the intensity of pruritus on a 5-point scale (from absent to very severe)
- change in the quality of sleep [from baseline to Day56]
The dermatologist evaluates the intensity of pruritus on a 5-point scale (from unaffected to very severely affected)
- change in the daily discomfort [from baseline to Day56]
The dermatologist evaluates the intensity of the daily discomfort on a 5-point scale (from absent to very severe)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dermatology practices | Zagreb | Croatia | ||
| 2 | Dermatology practices | Berlin | Germany | ||
| 3 | Dermatology practices | Lisboa | Portugal | ||
| 4 | Dermatology practices | Pretoria | South Africa | ||
| 5 | Dermatology practices | Taipei | Taiwan | ||
| 6 | Dermatology practices | Bangkok | Thailand | ||
| 7 | Dermatology practices | Hanoi | Vietnam |
Sponsors and Collaborators
- Cosmetique Active International
Investigators
- Study Director: Delphine Kerob, Cosmetique Active International
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LRP20001-LIPIKAR BAUME AP+M