Dry Skin; Eczema, Eczema, Psoriasis
Conditions
Brief 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.
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
Interventions
DEVICEEpaderm 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.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
infants (0-36 months old), children (3-18 years old) and adults (\>18 years old)
Eligibility
Sex/Gender
ALL
Age
4 Weeks to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improved Skin Moisturization | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improved Skin Softness | 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. |
| Number of Participants With Improved Overall Dry Skin/Xerosis | 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. |
| Number of Participants Who Confirmed Overall Effect and Comfort of Treatment | 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. |
| Number of Participants With Adverse Device Effects (ADEs) | 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. |
| Number of Participants Who Reported Applying Epaderm Cream Twice a Day | 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. |
| Number of Participants With Improvement of Skin Moisturization By Week 4 | 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. |
| Number of Participants Who Used Epaderm as a Skin Cleanser | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 121 |
| Total | 121 |
Baseline characteristics
| Characteristic | Epaderm Cream | — |
|---|---|---|
| Age, Categorical <=18 years | 36 Participants | — |
| Age, Categorical >=65 years | 41 Participants | — |
| Age, Categorical Between 18 and 65 years | 44 Participants | — |
| Age, Continuous | 30.5 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 121 participants | — |
| Sex: Female, Male Female | 51 Participants | — |
| Sex: Female, Male Male | 63 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 121 |
| other Total, other adverse events | 10 / 121 |
| serious Total, serious adverse events | 0 / 121 |
Outcome results
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:
Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epaderm Cream | Number of Participants With Improved Skin Moisturization | 114 Participants |
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.
Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epaderm Cream | Number of Participants Who Confirmed Overall Effect and Comfort of Treatment | 101 participants |
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.
Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epaderm Cream | Number of Participants Who Reported Applying Epaderm Cream Twice a Day | 67 Participants |
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.
Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported where participates answered 'yes'.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epaderm Cream | Number of Participants Who Used Epaderm as a Skin Cleanser | 75 Participants |
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.
Time frame: Evaluated at every follow-up visit (2 weeks and 4 weeks visit)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epaderm Cream | Number of Participants With Adverse Device Effects (ADEs) | 10 Participants |
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.
Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epaderm Cream | Number of Participants With Improved Overall Dry Skin/Xerosis | 100 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.
Time frame: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epaderm Cream | Number of Participants With Improved Skin Softness | 82 Participants |
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.
Time frame: Assessed at 2 weeks and 4 weeks visit. Improvement within 4 weeks visit reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epaderm Cream | Number of Participants With Improvement of Skin Moisturization By Week 4 | 107 Participants |