NCT05765461

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,631 (actual)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: —

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.

Conditions

• Atopic Dermatitis
• Skin Diseases

Timeline

• Start date: 2019-12-31
• Primary completion: 2022-11-28
• Completion: 2022-11-28
• First posted: 2023-03-13
• Last updated: 2024-07-01

Locations

7 sites across 7 countries: Croatia, Germany, Portugal, South Africa, Taiwan, Thailand, Vietnam