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

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

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 Overview

• Status: Completed
• Conditions: Psoriasis; Eczema; Dry Skin; Eczema
• Intervention / Treatment: Device: Epaderm Cream

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

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS8 2 PU
    • Whiteladies Medical Group
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2JB
      • Poole Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Epaderm Cream; This is an open, non randomised single arm study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Improved Skin Moisturization	Participants were considered to have improved moisturization if they responded strongly agree or agree on the questionnaire. Evaluations were carried out in the same affected spot from a scale of Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree where Strongly agree is the most improved skin moisturization:	Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Improved Skin Softness	Participants were considered to have improved softness if they responded strongly agree or agree on the questionnaire. Evaluations were carried out in the same affected spot from a scale of Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree where Strongly agree is the most improved skin softness.	Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
Number of Participants With Improved Overall Dry Skin/Xerosis	Participants were considered to have improved overall dry skin if they responded 'absent' or 'faint scaling' on the questionnaire. Evaluations were carried out in the same affected spot from a scale of 0= Absent, 1= Faint scaling, faint roughness and dull appearance, 2= Small scales in combination with a few larger scales, slight roughness, whitish appearance, 3= Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4= Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks where 'absent' or 'fanit scaling' refers to improved overall dry skin.	Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
Number of Participants Who Confirmed Overall Effect and Comfort of Treatment	Participants confirmed the comfort during treatment from a scale of Very Poor, Poor, Average, Good and Excellent where Excellent is considered the most comforting during treatment.	Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
Number of Participants With Adverse Device Effects (ADEs)	Number of Adverse Device Effects (ADEs) related to the use of Epaderm Cream during the investigation.	Evaluated at every follow-up visit (2 weeks and 4 weeks visit)
Number of Participants Who Reported Applying Epaderm Cream Twice a Day	Frequency of Epaderm Cream application. Participants were asked how often Epaderm Cream was applied either once a day, twice a day, three times a day or four times a day with twice a day application being the most frequent.	Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
Number of Participants With Improvement of Skin Moisturization By Week 4	Participants confirmed the time to visualize improvement of skin moisturization from the range immediately, within 2 weeks or not at all where immediately refers to the most increased improvements seen.	Assessed at 2 weeks and 4 weeks visit. Improvement within 4 weeks visit reported.
Number of Participants Who Used Epaderm as a Skin Cleanser	Participants were asked to confirm if the product was used as a skin cleanser by answering yes or no where yes confirmed use of Epaderm cream as a skin cleanser.	Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported where participates answered 'yes'.

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Suzannah August, MD, Poole Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): October 25, 2019
• Study Completion (Actual): June 17, 2020

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Dermatitis; Skin Diseases, Eczematous; Psoriasis; Eczema
• Other Study ID Numbers: Epaderm01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No