Emollients in the management of atopic dermatitis in children: prevention of flares. - Emollients in the management of AD

PIERRE FABRE MEDICAMENT0 个研究点目标入组 347 人开始时间: 2013年1月21日最近更新: 2019年6月30日

适应症

试验速览

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•Patients, male or female children, presenting with the following criteria may be included (V1):
•Age between 2 and 6 years included,
•- Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working Party,
•- Who has presented within the previous 6 months at least one duly documented flare treated by corticosteroids,
•- Who present a current flare,
•- Whose objective SCORAD score is [15-40] (grade 3) at inclusion,
•- Whose parent(s) or guardian(s) has given his/her (their) written consent for their child's participation in the study,
•- Whose parent(s) or guardian(s) is (are) cooperative with regard to compliance with study-related constraints,
•- Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).
•After treatment of the current flare, patients should have for randomization (V2):
•- Objective SCORAD score is < 15,
•- No lichenification, no excoriation, no oozing/crusts, no oedema/papulation,
•- Erythema intensity = 1 (residual erythema area = 10% of extent),
•- Xerosis intensity>= 1
•- No pruritus, no sleep disorders (< 1 on VAS of SCORAD).
•If lesions are not cleared in 21 days, patient cannot be randomized.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 409
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•* Criteria related to pathologies
•- Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
•- Primary bacterial, viral, fungal or parasitic skin infection,
•- Ulcerated lesions, acne or rosacea,
•- Dermatological disease other than atopic dermatitis which could interfere with the assessment,
•- Immunosuppression,
•- History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
•* Criteria related to treatments
•- Use of oral corticosteroids or immunosuppressants during the last 14 days,
•- Use of topical corticosteroids during the last 7 days,
•- Use of systemic or local antibiotics on the lesions during the last 7 days,
•- Use of non-steroid anti-inflammatory drugs or antihistamines during the last 7 days,
•- Regular use of food supplements that could, in the opinion of the investigator, modify skin properties (e.g. synbiotics),
•- History of hypersensitivity or intolerance to one of the components of the tested or associated products, or to cosmetics.

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