Explorative analysis of topical miltefosine application in adult patients with atopic dermatitis. - Miltefosin bei AD

Prof. Dr. med. Margitta Worm0 个研究点开始时间: 2007年7月6日最近更新: 2013年1月7日

试验速览

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•Subjects with diagnosed atopic dermatitis according to the criteria of Hanifin and Rajika
•Chronic course of atopic dermatitis
•Adult patients aged over 18 years
•Two comparable skin lesional areas of about 10 cm2, areas have to be suitable for taking skin biopsies
•Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year), refer to protocol chapter 6.1
•Informed consent signed and dated
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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

•Erythrodermia
•Other chronic inflammatory skin disease
•Malignant skin lesions
•Clinically significant abnormalities in haematology and clinical chemistry
•History or concomitant retinal pathology
•Known hypersensitivity to the study drug or active control
•Oral anti-histamines within 3 days before start of treatment
•Use of topical products at test areas, except ointments used for skin care within 3 days before start of treatment
•Use of topical corticosteroids at treatment sides within 14 days before start of treatment
•Treatment with UV including PUVA within 4 weeks before start of treatment
•Systemic immunosuppressives treatment including corticosteroids and immunomodulators within 4 weeks before start of treatment
•Coagulating disorders and anti-coagulant treatment within 4 weeks before the planned biopsies
•Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study within 4 weeks before start of treatment (investigator’s decision).
•Immunodeficiency including HIV
•Index-lesions covering breast implants
•Subjects who are inmates of psychiatric wards, prisons, or other state institutions.
•Pregnancy or lactation
•Participation in another clinical trial within the last 30 days.
•Other reasons that make the subject ineligible to participate in that clinical trial, i.e. drug and alcohol abuses, expectant incompliance

发起方

Prof. Dr. med. Margitta Worm