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

NCT ID: NCT05765461

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4631 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2022-11-28

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.

Conditions

Atopic Dermatitis; Skin Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cosmetique Active International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Delphine Kerob

Role: STUDY_DIRECTOR

Cosmetique Active International

Locations

Dermatology practices

Zagreb, , Croatia

Dermatology practices

Berlin, , Germany

Dermatology practices

Lisbon, , Portugal

Dermatology practices

Pretoria, , South Africa

Dermatology practices

Taipei, , Taiwan

Dermatology practices

Bangkok, , Thailand

Dermatology practices

Hanoi, , Vietnam

Countries

Croatia; Germany; Portugal; South Africa; Taiwan; Thailand; Vietnam

Other Identifiers

LRP20001-LIPIKAR BAUME AP+M

Identifier Type: -

Identifier Source: org_study_id