Centroderm GmbH
Wuppertal, Deutschland, 42287, Germany
NCT Number: NCT04097327
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.
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Notify Me18 year–65 year
All sexes
Observational
Wuppertal, Deutschland, 42287, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of Ectoin Dermatitis Cream in accordance with the instructions for use
Time frame: baseline (pretreatment), 8 hours after first application (post 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.
Time frame: baseline (pretreatment), 8 hours after first application (post 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.
Time frame: baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Skin hydration will be measured with a Tewameter. Physicians will measure values before (pretreatment), and after 1, 8 and 24 hours (post application).
Time frame: baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Skin barrier function will be measured with a Corneometer. Physicians will measure values before (pretreatment), and after 1, 8 and 24 hours (post application).
Time frame: baseline and 7 days after treatment
Skin hydration will be measured with a Tewameter. Physicians will measure values before (pretreatment), and 7 days after multiple applications.
Time frame: baseline and 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.
Bitop AG
Industry
Effect of Ectoin Dermatitis Cream 7% (EHK02) on Skin Hydration and Skin Barrier Function in Patients With Atopic Dermatitis: a Prospective, Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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