Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, corticosteroids, SCORAD
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).
Interventions
OTHERLipikar Baume AP+M
application of Lipikar Baume AP+M twice daily for 3 months in parallel with the corticosteroid treatment
OTHERUsual emollient
application of the usual emollient twice daily for 3 months in parallel with the corticosteroid treatment
Sponsors
Cosmetique Active International
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of treatments | from baseline to Day84 | the efficacy of treatments is evaluated by corticosteroids consumption (weight of product and number of applications) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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. |
| 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) |
Countries
Slovakia
Outcome results
None listed