Impact of the Daily Use of Emollient on Corticosteroids Consumption in Patients With Atopic Dermatitis

Impact of the Daily Use of the Tested Emollient on Corticosteroids Consumption in Patients Minimum 3 Years Old With Atopic Dermatitis (SCORAD 20-30) Versus Their Usual Emollient

This study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Lipikar Baume AP+M; Other: Usual emollient

Detailed Description

The study is conducted in compliance, as closely as possible, with the current version of the world medical association declaration of Helsinki, local regulations based on International Council on Harmonisation (ICH) guidelines for Good Clinical Practice.

The primary objective of this study is to compare the tested emollient and the usual emollient through the weight of used dermocorticosteroid. The weight of used dermocorticosteroid is compared at the end of the study by a Student t-test (or a non parametric Wilcoxon test depending on the data distribution).

The following hypotheses are used for the estimation of the sample size calculation:

• Power (1 - β) = 80%
• Two-sided significance level (α) = 5%
• Expected inter-group difference = 0.6g
• Standard deviation = 1.4g.

Statistical analyses is performed with SAS® version 9.4 or higher (SAS institute, North Carolina, USA).

Continuous variables are summarized as number of observations, mean, standard deviation, standard error, median, minimum and maximum (95% confidence interval will be provided if necessary). For categorical variables, subject counts and percentages will be provided.

Analyses use 2-sided tests at the 5% significance level, except the normality tested at the threshold of 1% (Shapiro-Wilk test).

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Slovakia
  • Svidník, Slovakia, 08901
    • DOST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients meeting the inclusion and exclusion criteria and agreeing to participate in the study

Description

Inclusion Criteria:

• diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features)
• mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion between 20 and 30)
• able to apply the emollient (each morning and evening) during a three-month period

Exclusion Criteria:

• presenting with another dermatological condition that could interfere with clinical evaluation
• having received any systemic treatment, including PUVAtherapy for atopic dermatitis in the month prior to Day 0
• who intend to expose themselves to the sun during the trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lipikar Baume AP+M; The group applies Lipikar Baume AP+M twice daily for 3 months. Participants have 4 visits (Day0, Day 28, Day56, Day84) with different outcome measures including self-evaluations).	Other: Lipikar Baume AP+M; application of Lipikar Baume AP+M twice daily for 3 months in parallel with the corticosteroid treatment
Usual emollient; The group applies their usual emollient twice daily for 3 months. Participants have 4 visits (Day0, Day28, Day56, Day84 with different outcome measures including self-evaluations).	Other: Usual emollient; application of the usual emollient twice daily for 3 months in parallel with the corticosteroid treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of treatments	the efficacy of treatments is evaluated by corticosteroids consumption (weight of product and number of applications)	from baseline to Day84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in SCORing Atopic Dermatitis (SCORAD) measure	evaluation of SCORAD by the dermatologist in relation with the emollient consumption (weight of product and number of applications)	from baseline to Day84
change in Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) measure	evaluation of PO-SCORAD by the patient in relation with the emollient consumption (weight of product and number of applications)	from baseline to Day84
change in LOCAL SCORing Atopic Dermatitis (LOCAL SCORAD) measure	evaluation of LOCAL SCORAD by the dermatologist in relation with the emollient consumption (weight of product and number of applications)	from baseline to Day84
change in cutaneous discomfort	evaluation of skin sensation (itching, tingling, burning) by the patient on a 4-point scale (from absence to severe)	from baseline to Day84
change in global efficacy	evaluation of global efficacy by the patient on a 4-point scale (from nil to excellent)	from Day28 to Day84
change in global tolerance	evaluation of global tolerance of the treatment (emollient + corticosteroid) by the patient on a 4-point scale (from nil to excellent)	from Day28 to Day84
change in Patient Benefit Index (PBI) measure	questionnaire filled in by the patient or the patient's parents (whether the statement applies to the situation or not, possible answers: not at all, somewhat, moderately, quite, very, does not apply to me)	from baseline to Day84
change in the quality of life (patients aged 18 years or over)	questionnaire about the Atopic Burden Scale for Adults (ABS-A) with the following scale: never, rarely, sometimes, often, very often, constantly, not applicable. A higher score means a higher burden.	from baseline to Day84
change in the quality of life (patients aged less than 18 years)	questionnaire about the Atopic Dermatitis Burden Scale for the Family (ABS-F) with the following scale: no, without hesitation; I don't know; maybe; yes, without hesitation; not applicable. A higher score means a higher burden.	from baseline to Day84

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Study Director: Caroline Le Floc'h, Cosmetique Active International

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): July 14, 2021

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: atopic dermatitis; corticosteroids; SCORAD
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Dermatologic Agents; Emollients
• Other Study ID Numbers: LRP19002-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