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This is an observational study which means only data are collected from participants about their experience and symptoms, who received their usual treatment without any intervention from the study sponsor.
Atopic dermatitis, also known as eczema, is a long-lasting skin disease that causes redness, swelling, dryness, cracking, and intense itching. Xerosis is the scientific wording to describe dry skin. This condition is caused by a weakened skin barrier that does not hold moisture well.
DIPROBASE® advanced eczema cream is already available for use in the UK. It moisturizes and protects the skin.
This study is being done to understand how people use DIPROBASE® Advanced Eczema Cream and how consistently they adhere to its recommended use in their daily routines. In this study, participants will be asked to fill in an online questionnaire about their eczema symptoms and experience with DIPROBASE® Advanced Eczema Cream.
No treatment advice will be given as a part of this study.
The main purpose of this study is to gather feedback from people in the UK who have used DIPROBASE® Advanced Eczema Cream to treat their eczema or their dry skin condition. To do this, researchers will collect the following information from participants:
It is planned to identify and collect user data from November 2024 to January 2025. Participants will be recruited through a consumer database available with an external partner or via social media.
In this study, only data are collected. No visits or tests are required as part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult users | Use of product 3 months prior to recruitment |
| |
| Caregivers of children (2-12 years old) | Use of product 3 months prior to recruitment |
| |
| Caregivers of children (<2 years old) | Use of product 3 months prior to recruitment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882) | Device | Product experience is assessed based on the answers provided by participants on the questions provided to them using an online questionnaire. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall intensity of the symptoms | Subjects will be asked to complete an online questionnaire assessing the overall intensity of their symptoms over the past three months, using a 4-point scale (0-no symptoms to 4-severe symptoms). | Retrospective analysis over three months |
| Coolness or soothing effect | Subjects will be asked to complete an online questionnaire assessing their experience with the product over the past three months, using a 7-point scale (0-strongly disagree to 7-strongly agree). | Retrospective analysis over three months |
| Symptoms relief (skin irritation, pain, dryness) | Subjects will be asked to complete an online questionnaire assessing their experience with the product over the past three months, using a 7-point scale (0-strongly disagree to 7-strongly agree). | Retrospective analysis over three months |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive summary of product usage: frequency, reasons, and ease of use | Subjects will be asked to complete an online questionnaire assessing various points on product utilization and product characteristics, i.e. the frequency with which they apply the product (once, twice, more than twice), the reasons for its use, whether they sought medical advice prior to commencing use, the number of consecutive days they used it, and their assessment of the ease of application (very easy, easy, neutral, difficult, very difficult). |
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Inclusion Criteria:
Participants:
Exclusion Criteria:
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The study focusses on two key populations:
Subjects will be recruited via a consumer panel / consumer database available with the external partner (contract research organization) and/or social media.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IQVIA Ltd. | London | W2 1AF | United Kingdom |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| Retrospective analysis over three months |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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