A Clinical Investigation With Epaderm® Cream

Psoriasis Clinical Trial

— PD-539878  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738163
• Other study ID #: Epaderm01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 17, 2020

Study information

• Verified date: June 2021
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 17, 2020
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Skin; Eczema
• Eczema
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Whiteladies Medical Group	Bristol
United Kingdom	Poole Hospital NHS Foundation Trust	Poole	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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.
Secondary	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'.