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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:
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| 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 |
| 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 |
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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
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patients meeting the inclusion criteria and agreeing to participate in the study
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| Name | Affiliation | Role |
|---|---|---|
| Delphine Kerob | Cosmetique Active International | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology practices | Zagreb | Croatia | ||||
| Dermatology practices |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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The dermatologist evaluates the inflammatory lesions surface with the following scale:
| 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 |
| Berlin |
| Germany |
| Dermatology practices | Lisbon | Portugal |
| Dermatology practices | Pretoria | South Africa |
| Dermatology practices | Taipei | Taiwan |
| Dermatology practices | Bangkok | Thailand |
| Dermatology practices | Hanoi | Vietnam |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |