Clinical trial NCT05644691: Impact of the Daily Use of Emollient on Corticosteroids Consumption in Patients With Atopic Dermatitis
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
corticosteroids
SCORAD
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 119
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients meeting the inclusion and exclusion criteria and agreeing to participate in the study

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: efficacy of treatments
timeFrame: from baseline to Day84
Secondary outcomes:
measure: change in SCORing Atopic Dermatitis (SCORAD) measure
timeFrame: from baseline to Day84
measure: change in Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) measure
timeFrame: from baseline to Day84
measure: change in LOCAL SCORing Atopic Dermatitis (LOCAL SCORAD) measure
timeFrame: from baseline to Day84
measure: change in cutaneous discomfort
timeFrame: from baseline to Day84
measure: change in global efficacy
timeFrame: from Day28 to Day84
measure: change in global tolerance
timeFrame: from Day28 to Day84
measure: change in Patient Benefit Index (PBI) measure
timeFrame: from baseline to Day84
measure: change in the quality of life (patients aged 18 years or over)
timeFrame: from baseline to Day84
measure: change in the quality of life (patients aged less than 18 years)
timeFrame: from baseline to Day84
Other outcomes:
Locations:
city: Svidník
country: Slovakia
facility: DOST
Study officials:
affiliation: Cosmetique Active International
name: Caroline Le Floc'h
role: STUDY_DIRECTOR
References: