A Clinical Investigation With Epaderm® Cream (PD-539878)

Molnlycke Health Care

Status: Completed

Conditions: Psoriasis; Dry Skin; Eczema; Eczema

Treatments: Device: Epaderm Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03738163

Epaderm01

Details and patient eligibility

About

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.

Full 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

Enrollment: 121 patients

Sex: All

Ages: 4+ weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

Epaderm Cream

Other group

Description:

This is an open, non randomised single arm study.

Treatment:

Device: Epaderm Cream