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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765461
• Other study ID #: LRP20001-LIPIKAR BAUME AP+M
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Cosmetique Active International
• Contact: Caroline Le Floc'h
• Phone: +33149646941
• Email: caroline.lefloch[@]loreal.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3931
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Skin Diseases

Locations

Country	Name	City	State
Croatia	Dermatology practices	Zagreb
Germany	Dermatology practices	Berlin
Portugal	Dermatology practices	Lisboa
South Africa	Dermatology practices	Pretoria
Taiwan	Dermatology practices	Taipei
Thailand	Dermatology practices	Bangkok
Vietnam	Dermatology practices	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the intensity of skin disease	The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)	from baseline to Day56
Secondary	change in the intensity of skin dryness	The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)	from baseline to Day56
Secondary	evolution of the inflammatory lesions surface	The dermatologist evaluates the inflammatory lesions surface with the following scale: none; <10%; [10%;30%[; >30%	from baseline to Day56
Secondary	change in the intensity of pruritus	The dermatologist evaluates the intensity of pruritus on a 5-point scale (from absent to very severe)	from baseline to Day56
Secondary	change in the quality of sleep	The dermatologist evaluates the intensity of pruritus on a 5-point scale (from unaffected to very severely affected)	from baseline to Day56
Secondary	change in the daily discomfort	The dermatologist evaluates the intensity of the daily discomfort on a 5-point scale (from absent to very severe)	from baseline to Day56