Phase
Condition
Dermatitis, Atopic
Allergy
Rash
Treatment
Study product
Placebo
Clinical Study ID
Ages 3-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Specific
Sex: female and/or male;
Age: from 3 months up to 12 years old;
Phototype: I to IV;
100% with atopic skin;
100% with sensitive skin;
Subject who had at least 3 eczema flares-up of atopic dermatitis during the last 6months before start of the study, including the crisis observed on D-X.
Subject presenting on the visit D-X a flare-up of eczema for which the dermatologistprescribed treatment with topical corticosteroids treatment;
Subjects with SCORAD between 15 and 40 on D-X;
Subject who do not require medical treatment anymore after using prescribed topicalcorticosteroids from D-X up to D0 and clinical signs of atopic dermatitis areresolved, to be defined on D0 visit (in case of insufficient healing of inflammatorylesions, the subject continues medical treatment as recommended by theinvestigator).
General
Healthy subject;
Child whose at least one parent/legal guardian has given freely and expresslyher/his informed consent;
Child whose at least one parent/legal guardian is willing to adhere to the protocoland study procedures;
Polish citizenship.
Exclusion
Exclusion Criteria:
Cutaneous pathology on the study zone other than atopic dermatitis;
Use of topical or systemic treatment during the previous weeks liable to interferewith the assessment of the efficacy of the study products, including anti-histaminictreatment (except prescribed dermocorticoids on D-X and in case of flare-up duringthe study course);
Subject having undergone a surgery under general anesthesia within the previousmonth;
Excessive exposure to sunlight or UV-rays within the previous month;
Subject enrolled in another clinical trial during the study period (concerns thestudied zones);
Subjects presenting oozing eczema lesions or any sign of infection on eczema lesions (e.g; pus).
Study Design
Connect with a study center
EUROFINS
Gdansk, Poméranie 82-210
PolandActive - Recruiting

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