At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Post Market Clinical Follow-up Investigation With Epaderm® Cream to Confirm Performance and Safety Parameters
In Brief
A clinical study evaluating Epaderm Cream for Eczema and 2 related conditions. Completed, enrolled 121 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.