Clinical trial NCT05765461: Effect of Lipikar Baume AP+M on Quality of Life and Pain of Adults With Dryness or Severe Xerosis
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Skin Diseases
Keywords: atopic dermatitis
severe xerosis
quality of life
dryness
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 4631
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients meeting the inclusion criteria and agreeing to participate in the study

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in the intensity of skin disease
timeFrame: from baseline to Day56
Secondary outcomes:
measure: change in the intensity of skin dryness
timeFrame: from baseline to Day56
measure: evolution of the inflammatory lesions surface
timeFrame: from baseline to Day56
measure: change in the intensity of pruritus
timeFrame: from baseline to Day56
measure: change in the quality of sleep
timeFrame: from baseline to Day56
measure: change in the daily discomfort
timeFrame: from baseline to Day56
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Dermatology practices
city: Berlin
country: Germany
facility: Dermatology practices
city: Lisboa
country: Portugal
facility: Dermatology practices
city: Pretoria
country: South Africa
facility: Dermatology practices
city: Taipei
country: Taiwan
facility: Dermatology practices
city: Bangkok
country: Thailand
facility: Dermatology practices
city: Hanoi
country: Vietnam
facility: Dermatology practices
Study officials:
affiliation: Cosmetique Active International
name: Delphine Kerob
role: STUDY_DIRECTOR
References: