Psoriasis Clinical Trial
Official title:
A Prospective Post Market Clinical Follow-up Investigation With Epaderm® Cream to Confirm Performance and Safety Parameters
This investigation is designed as a prospective, non-randomised, single arm clinical investigation. Data is collected from approximately 120 evaluable subjects, divided into three groups of approximately 40 subjects; infants (0-36 months old), children (3-18 years old) and adults (>18 years old), with the following indications: eczema, psoriasis and other dry skin conditions. Each subject will be followed during 4 weeks treatment, with a visit at baseline (visit 1), at 2 weeks (visit 2) and at 4 weeks (visit 3) treatment.
Primary Endpoint Skin hydration after treatment with Epaderm Cream up to 4 weeks, evaluated by the subject using a questionnaire. Secondary Endpoints 1. Skin hydration after treatment with Epaderm Cream up to 4 weeks, evaluated by investigator/nurse using a questionnaire. 2. Skin hydration after treatment with Epaderm Cream up to 4 weeks, using a non-invasive device MoistureMeterEpiD. 3. Investigator/nurse evaluation of skin softness after 2 and 4 weeks treatment, using a questionnaire. 4. Subject evaluation of skin softness after 2 and 4 weeks treatment, using a questionnaire. 5. Investigator/nurse evaluation regarding: - Clinical signs/conditions of the affected skin and changes thereof - Did the product prolong the relapse period for flares? 6. Subject evaluation regarding: - Did you use Epaderm Cream according to prescription? - Comfort during treatment - Time of onset of effect - Did the product have the expected effect - Overall impression - Was the investigational device used as a skin cleanser? 7. Concomitant and previous medication and treatment 8. Number of Adverse Device Effects (ADEs) related to the use of Epaderm Cream during the investigation ;
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