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Completed

NCT Number: NCT05765461

Effect of Lipikar Baume AP+M on Quality of Life and Pain of Adults With Dryness or Severe Xerosis

This study aims at evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. Patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. They may be prescribed a corticosteroid upon decision of the dermatologist.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatology practices, Zagreb, Croatia

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About this study

The general approach of the statistical methodology is the following:

  • The qualitative variables are described with number and percent of each level.
  • The quantitative variables are described with mean and standard deviation.
  • All statistical hypotheses are performed at the 5% significance level using 2-sided tests.
  • Given the large sample size, no normality assessment will be done.
  • Mean reduction rate for quantitative variables is calculated as (mean v0 - mean v1)/mean v0)*100.
  • Due to the high number of zeros at inclusion in the self-assessment quantitative criteria, analyses will concern only patient with an intensity above 0 at inclusion or at final visit.
  • Response rate for qualitative variables is calculated as the percent of patients with at least on level decrease between the two visits.
  • Response rate for satisfaction is the percent of patients declaring being Satisfied or Very satisfied.
  • Response rate for tolerance is the percent of patients declaring the tolerance High or Excellent.

Who can participate

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

Inclusion criteria

  • atopic dermatitis or other skin disease with dryness or severe xerosis

Exclusion criteria

  • patients not suffering from atopic dermatitis or other skin disease with dryness or severe xerosis

Treatment and study plan

Primary outcomes

  1. change in the intensity of skin disease

    Time frame: from baseline to Day56

    The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)

Secondary outcomes

  1. change in the intensity of skin dryness

    Time frame: from baseline to Day56

    The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)

  2. evolution of the inflammatory lesions surface

    Time frame: from baseline to Day56

    The dermatologist evaluates the inflammatory lesions surface with the following scale:

    • none
    • <10%
    • [10%;30%[
    • >30%

  3. change in the intensity of pruritus

    Time frame: from baseline to Day56

    The dermatologist evaluates the intensity of pruritus on a 5-point scale (from absent to very severe)

  4. change in the quality of sleep

    Time frame: from baseline to Day56

    The dermatologist evaluates the intensity of pruritus on a 5-point scale (from unaffected to very severely affected)

  5. change in the daily discomfort

    Time frame: from baseline to Day56

    The dermatologist evaluates the intensity of the daily discomfort on a 5-point scale (from absent to very severe)

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

Effect of Lipikar Baume AP+M on Quality of Life and Pain Related to Atopic Dermatitis and Other Skin Diseases With Dryness or Severe Xerosis on Adults

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2023
Registry last updated
Jul 1, 2024

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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