Comparison of Moisturisers for the Prevention of Atopic Dermatitis Relapse– a Randomised, Double Blind Controlled Study (COMPADRE)

ACO Hud Nordic AB0 个研究点目标入组 200 人开始时间: 2011年6月14日最近更新: 2012年12月17日

适应症

试验速览

暂无简介。

•1) Willing and able to provide informed consent
•2) Male or female and aged 18 years or above
•3) Diagnosis of AD according to UK working party 1994 (27), i.e.:
•a) Any itching skin condition
•b) Three or more of the following:
•i) History of flexural involvement, e.g. front of elbows, behind the knees, front of ankles, around the neck
•ii) Personal history of other atopic disease, e.g. asthma or hay fever
•iii) History of a generally dry skin in the last 12 months
•iv) Visible flexural dermatitis, e.g. front of elbows, behind the knees, front of ankles, around the neck
•v) Onset below age 2
•4) Visible atopic eczema of body surface area corresponding to a total area of at least the size of one palm of the patient’s hand
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1) Eczema exclusively on the hands
•2) Hypersensitivity or allergy to the test product (Canoderm), to the reference product (base cream), to the products used in the stabilisation phase (Miniderm, hydrocortisone cream 1%,
•mometasone furoate cream 0.1%), or to chemically related products
•3) Any serious current medical condition which, in the opinion of the Investigator, may interfere with the evaluation of the results or may be contraindicated by the use of the test medications
•4) Use of any concomitant medication that may interfere with the study related activities or
•assessment of efficacy, as judged by the Investigator
•5) Female patient who, according to the patient, is pregnant or breast-feeding, or plans to become pregnant during the course of the study
•6) Any patient-related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse), as judged by the Investigator
•7) Enrolment in any investigational study or use of an investigational drug within 3 months prior
•to the screening visit

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