ClinicalTrials.gg
CompletedNCT06747897Updated Jan 17, 2025

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 in Dermatitis, Atopic, sponsored by Bayer. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Dermatitis, Atopic

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Keywords

  • Dry skin / Xerosis
03

In context

Dermatitis, Atopic

1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's enrollment of 300 is above the median of 150 across 241 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  • Due to the real-world nature of the study, there are no exclusion criteria.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • Adult users

    Use of product 3 months prior to recruitment

    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

    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

    Device: MINERAL OIL + PETROLATUM (DIPROBASE® Advanced Eczema Cream, BAY987534, UI 1613882)

Interventions

  • DeviceMINERAL 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Retrospective analysis over three months

  2. 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).

    Time frame: Retrospective analysis over three months

  3. 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).

    Time frame: 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).

    Time frame: Retrospective analysis over three months

07

Study locations

1 site
  • IQVIA Ltd.
    London, W2 1AF, United Kingdom
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2024 to primary completion in Dec 2024, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2024
First posted
Dec 24, 2024
StartActual
Nov 28, 2024
Primary completionActual
Dec 12, 2024
CompletionActual
Dec 12, 2024
Last update
Jan 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06747897
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Dec 24, 2024
Start date
Nov 28, 2024
Primary completion
Dec 12, 2024
Completion
Dec 12, 2024
Last update
Jan 17, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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