A Clinical Investigation With Epaderm® Cream
This investigation is designed as a prospective, non-randomised, single arm clinical investigation. Data will be 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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A and Over|
Inclusion Criteria:1. Subjects suitable for treatment with Epaderm Cream, as deemed by the investigator and according to intended use (eczema, psoriasis and other dry skin conditions). 2. Subject or subject's legal representative must be able to read and sign the Patient Information and Consent Form.
Exclusion Criteria:1. Known allergy/hypersensitivity to any of the components of Epaderm Cream. 2. Subject not suitable for the investigation according to the investigator's judgement. 3. Subject participating in other ongoing similar clinical studies or other clinical studies which could interfere with this investigation, as judged by the investigator. 4. Subject previously enrolled in the current clinical investigation.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Molnlycke Health Care AB|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Eczema, Psoriasis, Dry Skin; Eczema|
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.
- - 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.
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