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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738163
Recruitment Status : Active, not recruiting
First Posted : November 13, 2018
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

Brief Summary:
This investigation is designed as a prospective, non-randomised, single arm clinical investigation. Data will be 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.

Condition or disease Intervention/treatment Phase
Eczema Psoriasis Dry Skin; Eczema Device: Epaderm Cream Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Intervention Model: Single Group Assignment
Intervention Model Description: infants (0-36 months old), children (3-18 years old) and adults (>18 years old)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Post Market Clinical Follow-up Investigation With Epaderm® Cream to Confirm Performance and Safety Parameters
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : October 25, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Skin hydration after treatment with Epaderm Cream up to 4 weeks, evaluated by the subject using a questionnaire. [ Time Frame: Evaluated at every follow-up visit (2 weeks and 4 weeks visit) ]
    Skin hydration will be evaluated by the subject, after treatment with Epaderm Cream up to 4 weeks, using a questionnaire. The subject will describe the perception of skin hydration after treatment with Epaderm Cream by answering the following question: • Improved Moisturisation? (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). The data will be presented with descriptive statistics by visit.


Secondary Outcome Measures :
  1. Skin hydration after treatment with Epaderm Cream up to 4 weeks, evaluated by investigator/nurse [ Time Frame: Evaluated at every follow-up visit (2 weeks and 4 weeks visit) ]
    Skin hydration after treatment with Epaderm Cream up to 4 weeks, evaluated by investigator/nurse using a questionnaire. The investigator/nurse will describe the perception of skin hydration after treatment with Epaderm Cream by answering the following question: • Improved Moisturisation? (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). The data will be presented with descriptive statistics by visit.

  2. Skin hydration measured up to 4 weeks treatment, with a non-invasive device, MoistureMeterEpiD [ Time Frame: Evaluated at baseline and every follow-up visit (2 weeks and 4 weeks visit) ]
    Skin hydration after treatment with Epaderm Cream up to 4 weeks, using a non-invasive device MoistureMeterEpiD. The device displays percentage water content (%). The data will be presented with descriptive statistics by visit.

  3. Skin softness evaluated up to 4 weeks treatment, by the subject using a questionnaire [ Time Frame: Evaluated at every follow-up visit (2 weeks and 4 weeks visit) ]
    Skin softness will be evaluated by the subject, after treatment with Epaderm Cream up to 4 weeks, using a questionnaire. The subject will describe the perception of skin softness after treatment with Epaderm Cream by answering the following question: • Improved Softness? (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). The data will be presented with descriptive statistics by visit.

  4. Skin softness evaluated up to 4 weeks treatment, by the investigator/nurse using a questionnaire [ Time Frame: Evaluated at every follow-up visit (2 weeks and 4 weeks visit) ]
    The investigator/nurse will describe the perception of skin softness after treatment with Epaderm Cream by answering the following question: • Improved Softness? (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). The data will be presented with descriptive statistics by visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738163


Locations
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United Kingdom
Poole Hospital NHS Foundation Trust
Poole, Dorset, United Kingdom, BH15 2JB
Whiteladies Medical Group
Bristol, United Kingdom, BS8 2 PU
Sponsors and Collaborators
Molnlycke Health Care AB

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Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT03738163    
Other Study ID Numbers: Epaderm01
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Eczema
Skin Diseases, Papulosquamous
Skin Diseases
Dermatitis
Skin Diseases, Eczematous