check_circleStudy Completed

Dermatitis, Atopic

Bayer Identifier:

22924

ClinicalTrials.gov Identifier:

NCT06747897

EudraCT Number:

Not Available

EU CT Number:

Not Available
An Observational Study to Gather Real-World User Feedback on DIPROBASE® Advanced Eczema Cream in Adults and Children with Eczema or Dry Skin

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • 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.
  • - Due to the real-world nature of the study, there are no exclusion criteria.

Trial summary

Enrollment Goal
300
Trial Dates
November 2024 - December 2024
Phase
N/A
Could I Receive a placebo
No
Products
Diprobase (BAY987534)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
IQVIA Ltd.London, W2 1AF, United Kingdom

Primary Outcome

  • 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).
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    Retrospective analysis over three months

Secondary Outcome

  • 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).
    date_rangeTime Frame:
    Retrospective analysis over three months

Trial design

Retrospective Consumer Experience on former use of DIPROBASE Advanced Eczema Cream® UI 1613882
Trial Type
Observational
Intervention Type
Device
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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