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

Completed

• Conditions: Skin Diseases; Atopic Dermatitis

• Registration Number: NCT05765461
• Lead Sponsor: Cosmetique Active International

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.

Study Timeline

• Study Start: 2019-12-31
• Primary Completion: 2022-11-28
• Study Completion: 2022-11-28
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4631

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in the intensity of skin disease	from baseline to Day56	The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)

Secondary Outcome Measures

Name	Time	Method
change in the intensity of skin dryness	from baseline to Day56	The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)
evolution of the inflammatory lesions surface	from baseline to Day56	The dermatologist evaluates the inflammatory lesions surface with the following scale: * none; * \<10%; * \[10%;30%\[; * \>30%
change in the intensity of pruritus	from baseline to Day56	The dermatologist evaluates the intensity of pruritus on a 5-point scale (from absent to very severe)
change in the quality of sleep	from baseline to Day56	The dermatologist evaluates the intensity of pruritus on a 5-point scale (from unaffected to very severely affected)
change in the daily discomfort	from baseline to Day56	The dermatologist evaluates the intensity of the daily discomfort on a 5-point scale (from absent to very severe)

Trial Locations

Locations (1)

Dermatology practices; 🇻🇳 Hanoi, Vietnam