NCT03738163

A Clinical Investigation With Epaderm® Cream

A Prospective Post Market Clinical Follow-up Investigation With Epaderm® Cream to Confirm Performance and Safety Parameters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Eczema
• Psoriasis
• Dry Skin; Eczema

Interventions

Type	Name	Description
DEVICE	Epaderm Cream	The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-10-25
• Completion: 2020-06-17
• First posted: 2018-11-13
• Last updated: 2021-06-23
• Results posted: 2021-06-07

Locations

2 sites across 1 country: United Kingdom