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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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