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    Summary
    EudraCT Number:2007-003471-39
    Sponsor's Protocol Code Number:Miltefosin bei AD
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2007-003471-39
    A.3Full title of the trial
    Explorative analysis of topical miltefosine application in adult patients with atopic dermatitis.
    A.3.2Name or abbreviated title of the trial where available
    Miltefosin bei AD
    A.4.1Sponsor's protocol code numberMiltefosin bei AD
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorProf. Dr. med. Margitta Worm
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Miltex®
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Oncology
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmiltefosine
    D.3.9.1CAS number 58066-85-6
    D.3.9.2Current sponsor codeMiltex®
    D.3.9.3Other descriptive nameVerum
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Hydrogalen® LÖSUNG
    D.2.1.1.2Name of the Marketing Authorisation holderGALENpharma
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhydrocortisone
    D.3.9.1CAS number 50-23-7
    D.3.9.2Current sponsor codeHydrogalen® LÖSUNG
    D.3.9.3Other descriptive nameactive control
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    active control (hydrocortisone)
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The clinical trial ends with the last visit (follow-up 2) of the last patient patient.
    (see protocol chapter 5)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    A treatment of atopic dermatitis is planned to be continued via the special consultation-hours for atopic dermatitis in the Allergy-Centre-Charité, Dpt. of Dermatology and Allergology, Charité – Universitätsmedizin Berlin.
    If a subject reports an AE at the end of study, or a previously reported AE is ongoing the investigator will follow-up this event until the event resolves or until there is a satisfactory explanation of the changes observed.
    (see protocol chapter 8.5.10)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-31
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