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Completed

NCT Number: NCT06747897

An Observational Study to Gather Real-World User Feedback on DIPROBASE® Advanced Eczema Cream in Adults and Children With Eczema or Dry Skin

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IQVIA Ltd.

London, W2 1AF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. Descriptive summary of product usage: frequency, reasons, and ease of use

    Time frame: Retrospective analysis over three months

    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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Retrospective Consumer Experience on Former Use of DIPROBASE Advanced Eczema Cream® UI 1613882

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2024
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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