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

Cosmetique Active

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: Usual emollient; Other: Lipikar Baume AP+M

Study type: Observational

Funder types: Industry

Identifiers

NCT05644691

LRP19002-LIPIKAR BAUME AP+M

Details and patient eligibility

About

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.

Full 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).

Enrollment: 119 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

119 participants in 2 patient groups

Lipikar Baume AP+M

Description:

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).

Treatment:

Other: Lipikar Baume AP+M

Usual emollient

Description:

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).

Treatment:

Other: Usual emollient