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Completed

NCT Number: NCT03738163

A Clinical Investigation With Epaderm® Cream

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.

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Key information

Conditions

Eczema Dermatitis Dry Skin; Eczema Psoriasis Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

4 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poole Hospital NHS Foundation Trust, Poole, Dorset, United Kingdom

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About this study

Primary Endpoint Skin hydration after treatment with Epaderm Cream up to 4 weeks, evaluated by the subject using a questionnaire.

Secondary Endpoints

  • Skin hydration after treatment with Epaderm Cream up to 4 weeks, evaluated by investigator/nurse using a questionnaire.
  • Skin hydration after treatment with Epaderm Cream up to 4 weeks, using a non-invasive device MoistureMeterEpiD.
  • Investigator/nurse evaluation of skin softness after 2 and 4 weeks treatment, using a questionnaire.
  • Subject evaluation of skin softness after 2 and 4 weeks treatment, using a questionnaire.
  • Investigator/nurse evaluation regarding:
  • Clinical signs/conditions of the affected skin and changes thereof
  • Did the product prolong the relapse period for flares?
  • 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?
  • Concomitant and previous medication and treatment
  • Number of Adverse Device Effects (ADEs) related to the use of Epaderm Cream during the investigation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects suitable for treatment with Epaderm Cream, as deemed by the investigator and according to intended use (eczema, psoriasis and other dry skin conditions).
  • Subject or subject's legal representative must be able to read and sign the Patient Information and Consent Form.

Exclusion criteria

  • Known allergy/hypersensitivity to any of the components of Epaderm Cream.
  • Subject not suitable for the investigation according to the investigator's judgement.
  • Subject participating in other ongoing similar clinical studies or other clinical studies which could interfere with this investigation, as judged by the investigator.
  • Subject previously enrolled in the current clinical investigation.

Treatment and study plan

Epaderm Cream

Device

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 outcomes

  1. Number of Participants With Improved Skin Moisturization

    Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

    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:

Secondary outcomes

  1. Number of Participants With Improved Skin Softness

    Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

    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.

  2. Number of Participants With Improved Overall Dry Skin/Xerosis

    Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

    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.

  3. Number of Participants Who Confirmed Overall Effect and Comfort of Treatment

    Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

    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.

  4. Number of Participants With Adverse Device Effects (ADEs)

    Time frame: Evaluated at every follow-up visit (2 weeks and 4 weeks visit)

    Number of Adverse Device Effects (ADEs) related to the use of Epaderm Cream during the investigation.

  5. Number of Participants Who Reported Applying Epaderm Cream Twice a Day

    Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

    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.

  6. Number of Participants With Improvement of Skin Moisturization By Week 4

    Time frame: Assessed at 2 weeks and 4 weeks visit. Improvement within 4 weeks visit reported.

    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.

  7. Number of Participants Who Used Epaderm as a Skin Cleanser

    Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported where participates answered 'yes'.

    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.

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study title

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

Acronym: PD-539878

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 13, 2018
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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