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

NCT ID: NCT05644691

Last Updated: 2022-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2021-07-14

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).

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Lipikar Baume AP+M

Intervention Type: OTHER

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).

Usual emollient

Intervention Type: OTHER

application of the usual emollient twice daily for 3 months in parallel with the corticosteroid treatment

Interventions

Lipikar Baume AP+M

application of Lipikar Baume AP+M twice daily for 3 months in parallel with the corticosteroid treatment

Intervention Type: OTHER

Usual emollient

application of the usual emollient twice daily for 3 months in parallel with the corticosteroid treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cosmetique Active International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Le Floc'h

Role: STUDY_DIRECTOR

Cosmetique Active International

Locations

DOST

Svidník, , Slovakia

Countries

Slovakia

Other Identifiers

LRP19002-LIPIKAR BAUME AP+M

Identifier Type: -

Identifier Source: org_study_id