Dermatitis, AtopicNCT06747897
An Observational Study to Gather Real-World User Feedback on DIPROBASE® Advanced Eczema Cream in Adults and Children With Eczema or Dry Skin
An observational study of Dermatitis, Atopic, run by Bayer at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882)
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Nov 2024to 12 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study focusses on two key populations: * Adult Population: Adults aged 18 years and above who have used DIPROBASE® Advanced Eczema Cream for their eczema management. * Pediatric Caregiver population: Adult caregivers of children aged 2-12 years and infants 2 years and under who have applied the product to treat their children/ward's eczema. Subjects will be recruited via a consumer panel / consumer database available with the external partner (contract research organization) and/or social media.
Who may be able to join
- Participants:
- Biological sex: M/F.
- Age: > or equal to 18 years of age.
- Mothers, fathers, grandparents, and other caregivers aged 18 years of age and above, who will report data on themselves, their children from 2 to 12 years of age or their infants under 2 years of age.
- Able to read and understand the language of the online questionnaire.
- Have used the product within the previous three (3) months.
- Agree that the data collected can be used for research, marketing and regulatory purposes.
Who cannot join
- Due to the real-world nature of the study, there are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Consumer Experience on Former Use of DIPROBASE Advanced Eczema Cream® UI 1613882
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.
Read more
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:
- intensity of eczema symptoms
- whether the cream provides a cooling or soothing effect
- whether the cream helps to ease the symptoms like itchiness, pain, or dryness
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.
- Conditions
- Dermatitis, Atopic
- Being tested
- MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882)
- Keywords
- Dry skin / Xerosis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult users | Use of product 3 months prior to recruitment Receives: Device: MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882) | |
| Caregivers of children (2-12 years old) | Use of product 3 months prior to recruitment Receives: Device: MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882) | |
| Caregivers of children (<2 years old) | Use of product 3 months prior to recruitment Receives: Device: MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Retrospective analysis over three months
Secondary outcomes (1)
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).
Measured: Retrospective analysis over three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start28 Nov 2024
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747897
- Sponsor's protocol ID
- 22924
- Status last verified
- Jan 2025
- First submitted
- 18 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Consumer Experience on Former Use of DIPROBASE Advanced Eczema Cream® UI 1613882
- ClinicalTrials.gov ID
- NCT06747897
- Acronym / sponsor ID
- 22924
- Conditions
- Dermatitis, Atopic
- Keywords
- Dry skin / Xerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- intensity of eczema symptoms
- whether the cream provides a cooling or soothing effect
- whether the cream helps to ease the symptoms like itchiness, pain, or dryness
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult users | – | Device: MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882)Use of product 3 months prior to recruitment |
| Caregivers of children (2-12 years old) | – | Device: MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882)Use of product 3 months prior to recruitment |
| Caregivers of children (<2 years old) | – | Device: MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882)Use of product 3 months prior to recruitment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study focusses on two key populations: * Adult Population: Adults aged 18 years and above who have used DIPROBASE® Advanced Eczema Cream for their eczema management. * Pediatric Caregiver population: Adult caregivers of children aged 2-12 years and infants 2 years and under who have applied the product to treat their children/ward's eczema. Subjects will be recruited via a consumer panel / consumer database available with the external partner (contract research organization) and/or social media.
Key inclusion criteria (7 listed)
- Biological sex: M/F.
- Age: > or equal to 18 years of age.
- Mothers, fathers, grandparents, and other caregivers aged 18 years of age and above, who will report data on themselves, their children from 2 to 12 years of age or their infants under 2 years of age.
- Able to read and understand the language of the online questionnaire.
- Have used the product within the previous three (3) months.
Key exclusion criteria (1 listed)
- Due to the real-world nature of the study, there are no exclusion criteria.
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 |
|---|---|---|
| MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882)Product experience is assessed based on the answers provided by participants on the questions provided to them using an online questionnaire. | Device | Adult users, Caregivers of children (2-12 years old), Caregivers of children (<2 years old) |
Primary outcome
Overall intensity of the symptoms
Time frame: Retrospective analysis over three months
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).
Coolness or soothing effect
Time frame: Retrospective analysis over three months
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).
Symptoms relief (skin irritation, pain, dryness)
Time frame: Retrospective analysis over three months
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).
1 secondary outcome
Descriptive summary of product usage: frequency, reasons, and ease of use
Time frame: Retrospective analysis over three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No. 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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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by Bayer at 1 site 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 7 inclusion and 1 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall intensity of the symptoms (time frame: Retrospective analysis over three months). The study lists 3 primary outcomes in all. 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 17 Jan 2025.