Atopic Dermatitis (AD) is a chronic, inflammatory skin disease combined with intense itching. Beside the existing genetic background, various environmental factors impact the pathophysiology. Topical steroids are widely used for the treatment of AD, but can be associated with local and systemic side effects. Efforts to introduce new treatment approaches are permanently ongoing. Immune regulative properties are supposed for miltefosine and it could be a new relevant agent for the therapy of AD.
Conditions
Interventions
Trade Name: Miltex®
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: miltefosine
CAS Number: 58066-85-6
Current Sponsor code: Miltex®
Other descriptive name: Verum
Concentration unit: mg/m
Sponsors
Prof. Dr. med. Margitta Worm
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The anti-inflammatory effect of topical miltefosine on inflammatory skin by patients with AD will be assessed in comparison to an active control (hydrocortisone). Changes in the TIS (Three Item Severity) score will provide information about the immune regulative effect of miltefosine by AD. To compare the anti-inflammatory properties of miltefosine with an active control two skin areas are treated differentially either with miltefosine or hydrocortisone. Therewith, a conclusion about the power of the anti-inflammatory effects of miltefosine could be drawn.;Secondary Objective: not applicable ;Primary end point(s): Clinical evaluation of treatment response using the TIS score (maximum = 9 points) evaluating erythema, oedema / papulation, and excoriation each on a 4-point scale (0 = no, 1 = mild, 2 = moderate, 3 = severe). A comparison between miltefosine and hydrocortisone (active control) will be made. Evaluation of further clinical parameter like the objective SCORAD (Severity Scoring of Atopic Dermatitis) will be additionally made. Change from baseline of immune histological parameters like CD4 / CD8 infiltrating cells induced by miltefosine will be explorative analysed. Furthermore, data will be collected for skin physiology and thermography and will be explorative utilised. The analysis of the endpoints will be exploratory and descriptive. Changes from baseline will be evaluated. Non-parametrical test, Wilcoxon test for paired data and Mann-Whitney U-test for unpaired data will be used. | — |
Countries
Germany
Outcome results
None listed