Clinical trial NCT03738163: A Clinical Investigation With Epaderm® Cream
Official title: A Prospective Post Market Clinical Follow-up Investigation With Epaderm® Cream to Confirm Performance and Safety Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Psoriasis
Dry Skin; Eczema
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2018-11-13
Enrollment: 121
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: infants (0-36 months old), children (3-18 years old) and adults (\>18 years old)
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Improved Skin Moisturization
timeFrame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
Secondary outcomes:
measure: Number of Participants With Improved Skin Softness
timeFrame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
measure: Number of Participants With Improved Overall Dry Skin/Xerosis
timeFrame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
measure: Number of Participants Who Confirmed Overall Effect and Comfort of Treatment
timeFrame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
measure: Number of Participants With Adverse Device Effects (ADEs)
timeFrame: Evaluated at every follow-up visit (2 weeks and 4 weeks visit)
measure: Number of Participants Who Reported Applying Epaderm Cream Twice a Day
timeFrame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
measure: Number of Participants With Improvement of Skin Moisturization By Week 4
timeFrame: Assessed at 2 weeks and 4 weeks visit. Improvement within 4 weeks visit reported.
measure: Number of Participants Who Used Epaderm as a Skin Cleanser
timeFrame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported where participates answered 'yes'.
Other outcomes:
Locations:
city: Poole
country: United Kingdom
facility: Poole Hospital NHS Foundation Trust
state: Dorset
city: Bristol
country: United Kingdom
facility: Whiteladies Medical Group
Study officials:
affiliation: Poole Hospital
name: Suzannah August, MD
role: PRINCIPAL_INVESTIGATOR
References: