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The aim of this prospective, uncontrolled clinical study is to evaluate the clinical effect of Ectoin® Dermatitis Cream-EHK02 on skin hydration and transepidermal water loss (TEWL) in subjects with atopic dermatitis after single and multiple applications. Furthermore, data concerning the subjective impression of the study preparation should be collected.
The principle mode of Ectoin is based on the physical interaction of this compatible solute with water. Ectoin® Dermatitis Cream 7% (EHK02) is able to build an Ectoin® Hydro Complex on the skin providing an effective protection against external stress factors, stabilizing the skin barrier and moisturizing the dry skin. In former studies, it has been shown that it can be used for the symptomatic treatment of atopic dermatitis. This study should confirm the efficacy and safety of EHK02.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ectoin Dermatitis Cream 7% (EHK02) | Other | Application of Ectoin Dermatitis Cream in accordance with the instructions for use |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean corneometer measurement 8 hours after treatment | Corneometer is a non-invasive instrument that measures barrier function of the skin surface. Change of skin hydration will be assessed comparing values before (initial condition-pretreatment) and after single application. The electrical capacitance of the skin surface will be expressed digitally in arbitrary units. Three measurements will be performed on each test area and the mean will be used to define the skin barrier function of the stratum corneum. | baseline (pretreatment), 8 hours after first application (post treatment) |
| Change from baseline in mean tewameter measurement 8 hours after treatment | Transepidermal water loss (TEWL) is affected by environmental factors as humidity, temperature, the time of year (seasonal variation) and the moisture content of the skin (hydration level). Tewameter is a non-invasive instrument that measures skin hydration. Change of skin hydration will be assessed comparing values before (initial condition-pretreatment) and after single application. The TEWL measurement will be measured three times and the mean than will be used to define skin hydration of the stratum corneum. The hydration of the skin surface will be expressed in g/hm². | baseline (pretreatment), 8 hours after first application (post treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin hydration over time (1, 8, and 24 hours) after single application compared to initial condition (pretreatment). | Skin hydration will be measured with a Tewameter. Physicians will measure values before (pretreatment), and after 1, 8 and 24 hours (post application). | baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals diagnosed with atopic dermatitis without flare up (in eczema free interval).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centroderm GmbH | Wuppertal | Deutschland | 42287 | Germany |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Change in skin barrier function over time (1, 8, and 24 h) after single application compared to initial condition (pretreatment). | Skin barrier function will be measured with a Corneometer. Physicians will measure values before (pretreatment), and after 1, 8 and 24 hours (post application). | baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment). |
| Change from baseline (initial condition) in mean Tewameter measurement 7 days after treatment. | Skin hydration will be measured with a Tewameter. Physicians will measure values before (pretreatment), and 7 days after multiple applications. | baseline and 7 days after treatment |
| Change from baseline (initial condition) in mean Corneometer measurement 7 days after treatment. | Skin barrier function will be measured with a Corneometer. Physicians will measure values before (pretreatment), and 7 days after multiple applications. | baseline and 7 days after treatment |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |