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

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Atopic Dermatitis

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 Type: Observational
• Enrollment (Actual): 4631

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia
    • Dermatology practices
• Germany
  • Berlin, Germany
    • Dermatology practices
• Portugal
  • Lisboa, Portugal
    • Dermatology practices
• South Africa
  • Pretoria, South Africa
    • Dermatology practices
• Taiwan
  • Taipei, Taiwan
    • Dermatology practices
• Thailand
  • Bangkok, Thailand
    • Dermatology practices
• Vietnam
  • Hanoi, Vietnam
    • Dermatology practices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients meeting the inclusion criteria and agreeing to participate in the study

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Study Director: Delphine Kerob, Cosmetique Active International

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): November 28, 2022

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; atopic dermatitis; dryness; severe xerosis
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Skin Diseases; Dermatitis, Atopic
• Other Study ID Numbers: LRP20001-LIPIKAR BAUME AP+M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No