Clinical trial NCT06747897: An Observational Study to Gather Real-World User Feedback on DIPROBASE® Advanced Eczema Cream in Adults and Children With Eczema or Dry Skin
Official title: Retrospective Consumer Experience on Former Use of DIPROBASE Advanced Eczema Cream® UI 1613882
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis, Atopic
Keywords: Dry skin / Xerosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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:

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

Primary outcomes:
measure: Overall intensity of the symptoms
timeFrame: Retrospective analysis over three months
measure: Coolness or soothing effect
timeFrame: Retrospective analysis over three months
measure: Symptoms relief (skin irritation, pain, dryness)
timeFrame: Retrospective analysis over three months
Secondary outcomes:
measure: Descriptive summary of product usage: frequency, reasons, and ease of use
timeFrame: Retrospective analysis over three months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: IQVIA Ltd.
Study officials:
References: