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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.
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:
Subject evaluation regarding:
Concomitant and previous medication and treatment
Number of Adverse Device Effects (ADEs) related to the use of Epaderm Cream during the investigation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epaderm Cream | Other | This is an open, non randomised single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzannah August, MD | Poole Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poole Hospital NHS Foundation Trust | Poole | Dorset | BH15 2JB | United Kingdom | ||
| Whiteladies Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epaderm Cream | This is an open, non randomised single arm study. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epaderm Cream | This is an open, non randomised single arm study. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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: | Posted | Count of Participants | Participants | Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported |
|
Adverse event data was collected over a period of 4 weeks from the baseline visit to the final follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epaderm Cream | This is an open, non randomised single arm study. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flare of eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sabrina Chowdhury | Mölnlycke Health Care | +44 (0)7769 907654 | sabrina.chowdhury@molnlycke.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2019 | Mar 1, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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infants (0-36 months old), children (3-18 years old) and adults (>18 years old)
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| 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'. |
| Bristol |
| BS8 2 PU |
| United Kingdom |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | 7 subjects withdrew from the study. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Number | participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported where participates answered 'yes'. |
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| 0 |
| 121 |
| 0 |
| 121 |
| 10 |
| 121 |
| Intermittent rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Redness & itch |
|
| Inflammatory reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Worsening of the skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D017444 |
| Skin Diseases, Papulosquamous |