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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05644691
• Other study ID #: LRP19002-LIPIKAR BAUME AP+M
• Status: Completed
• Start date: October 14, 2020
• Est. completion date: July 14, 2021

Study information

• Verified date: November 2022
• Source: Cosmetique Active International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 14, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Lipikar Baume AP+M
application of Lipikar Baume AP+M twice daily for 3 months in parallel with the corticosteroid treatment
• Usual emollient
application of the usual emollient twice daily for 3 months in parallel with the corticosteroid treatment

Locations

Country	Name	City	State
Slovakia	DOST	Svidník

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of treatments	the efficacy of treatments is evaluated by corticosteroids consumption (weight of product and number of applications)	from baseline to Day84
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	change in global efficacy	evaluation of global efficacy by the patient on a 4-point scale (from nil to excellent)	from Day28 to Day84
Secondary	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
Secondary	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
Secondary	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
Secondary	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