EczemaPD-539878NCT03738163
A Clinical Investigation With Epaderm® Cream
A study testing Epaderm Cream in people with Eczema and Psoriasis, run by Molnlycke Health Care AB at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 4 weeks and older
- Conditions the study is for
- Eczema, Psoriasis, Dry Skin; Eczema
- What is being tested?
- Epaderm Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Apr 2019to 17 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Whiteladies Medical Group
Bristol, BS8 2 PU
Poole Hospital NHS Foundation Trust
Poole, Dorset, BH15 2JB
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Eczema, Psoriasis, Dry Skin; Eczema
- Being tested
- Epaderm Cream
- Medical subject headings
- Eczema, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epaderm CreamDevice
The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
| Study group | Role | What they receive |
|---|---|---|
| Epaderm Cream | Other | This is an open, non randomised single arm study. Receives: Device: Epaderm Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported where participates answered 'yes'.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Apr 2019
- Primary completion25 Oct 2019
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- infants (0-36 months old), children (3-18 years old) and adults (\>18 years old)
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzannah August, MD, Principal investigator, Poole Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738163
- Sponsor's protocol ID
- Epaderm01
- Acronym
- PD-539878
- Status last verified
- Jun 2021
- First submitted
- 26 Oct 2018
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Post Market Clinical Follow-up Investigation With Epaderm® Cream to Confirm Performance and Safety Parameters
- ClinicalTrials.gov ID
- NCT03738163
- Acronym / sponsor ID
- PD-539878 / Epaderm01
- Conditions
- Eczema, Psoriasis, Dry Skin; Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 7 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- infants (0-36 months old), children (3-18 years old) and adults (>18 years old)
| Arm | Type | Receives |
|---|---|---|
| Epaderm Cream | Other | Device: Epaderm CreamThis is an open, non randomised single arm study. |
Who may qualify
- Ages
- 4 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epaderm CreamThe treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device. | Device | Epaderm Cream |
Primary outcome
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:
7 secondary outcomes
Number of Participants With Improved Skin Softness
Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
Number of Participants With Improved Overall Dry Skin/Xerosis
Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
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
Number of Participants With Adverse Device Effects (ADEs)
Time frame: Evaluated at every follow-up visit (2 weeks and 4 weeks visit)
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
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.
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'.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzannah August, MD principal investigator
Poole Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epaderm Cream in people with Eczema and Psoriasis, run by Molnlycke Health Care AB at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Improved Skin Moisturization (time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.