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

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: Usual emollient; Other: Lipikar Baume AP+M

• Registration Number: NCT05644691
• Lead Sponsor: Cosmetique Active International

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).

Study Timeline

• Study Start: 2020-10-14
• Primary Completion: 2021-07-14
• Study Completion: 2021-07-14
• Status Verified: 2022-11
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-30
• Last Update Submitted: 2022-11-30
• Study First Posted: 2022-12-09
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Usual emollient	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).
Lipikar Baume AP+M	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).

Primary Outcome Measures

Name	Time	Method
efficacy of treatments	from baseline to Day84	the efficacy of treatments is evaluated by corticosteroids consumption (weight of product and number of applications)

Secondary Outcome Measures

Name	Time	Method
change in the quality of life (patients aged 18 years or over)	from baseline to Day84	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.
change in global efficacy	from Day28 to Day84	evaluation of global efficacy by the patient on a 4-point scale (from nil to excellent)
change in SCORing Atopic Dermatitis (SCORAD) measure	from baseline to Day84	evaluation of SCORAD by the dermatologist in relation with the emollient consumption (weight of product and number of applications)
change in Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) measure	from baseline to Day84	evaluation of PO-SCORAD by the patient in relation with the emollient consumption (weight of product and number of applications)
change in global tolerance	from Day28 to Day84	evaluation of global tolerance of the treatment (emollient + corticosteroid) by the patient on a 4-point scale (from nil to excellent)
change in Patient Benefit Index (PBI) measure	from baseline to Day84	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)
change in LOCAL SCORing Atopic Dermatitis (LOCAL SCORAD) measure	from baseline to Day84	evaluation of LOCAL SCORAD by the dermatologist in relation with the emollient consumption (weight of product and number of applications)
change in cutaneous discomfort	from baseline to Day84	evaluation of skin sensation (itching, tingling, burning) by the patient on a 4-point scale (from absence to severe)
change in the quality of life (patients aged less than 18 years)	from baseline to Day84	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.

Trial Locations

Locations (1)

DOST; 🇸🇰 Svidník, Slovakia