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    Summary
    EudraCT Number:2009-012028-98
    Sponsor's Protocol Code Number:071-007
    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:2009-05-04
    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 number2009-012028-98
    A.3Full title of the trial
    A placebo-controlled, multicentre, double-blinded, intra-individual comparison to gain evidence of the safety, tolerability and efficacy of Prednicarbat cream and ointment in patients with active atopic dermatitis
    A.4.1Sponsor's protocol code number071-007
    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 SponsorGALENpharma GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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.3.1Product namePrednicarbat Creme (O/W) GALEN
    D.3.4Pharmaceutical form Cream
    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 INNPREDNICARBATE
    D.3.9.1CAS number 73771047
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeglucocorticoid
    D.IMP: 2
    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 No
    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.3.1Product namePrednicarbat Salbe GALEN
    D.3.4Pharmaceutical form Ointment
    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 INNPREDNICARBATE
    D.3.9.1CAS number 73771047
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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 Yes
    D.3.11.13.1Other medicinal product typeglucocorticoid
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOintment
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    active atopic dermatitis (according to IGA score 1 - 4)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is to gain evidence of the safety and local tolerability of Prednicarbat cream/Prednicarbat ointment compared to placebo, assessed by the severity, nature and frequency of AEs/SAEs, vital signs and the relationship to study medication. Tolerability will be assessed by examination of skin reactions after topical application of the IMPs by physician and patient.
    The patients’ assessment of tolerability (PaAT) will be assessed at all visits by means of the following subjective symptoms:
    - itching,
    - burning,
    - stinging and tightness of the skin
    after application of the IMPs.
    The physicians’ assessment of tolerability (PAT) will be assessed at all visits by means of the occurrence of the following objective skin symptoms:
    - occurrence of dermal atrophy and
    - telangiectasia
    - local infections,
    - folliculitis,
    - bruise (ecchymosis),
    - whitehead (milia),
    - local allergic reactions
    after the application of the IMPs.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to gain evidence of the tolerability and efficacy of Prednicarbat cream/Prednicarbat ointment compared to placebo.
    The patients’ global assessment of tolerability (PaGA) and the physicians’ global assessment of tolerability (PGA) will be assessed at the end of the trial.
    A physical examination will be performed.
    The efficacy is assessed by modified EASI (Modified Eczema Area and Severity Index).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients with a diagnosis of atopic dermatitis for ≥ 6 months, in active stage (active stage means severity as measured by IGA-Score between 1 and 4, Definition of IGA in Appendix)
    • At least two comparable areas of stable atopic eczema on bilateral symmetric corresponding sides of the extremities or the body (except for head and genital area), each of at least 10 cm², with a modified EASI score of the test areas > 6 and at least 60 % of the defined test areas afflicted with atopic dermatitis (Definition of modified EASI in Appendix)
    • Age between 18 and 75 years
    • A patient of childbearing potential agrees to use one of the following contraceptive methods for the duration of the study:
    o Strict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed)
    o Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance
    o Intrauterine device (IUD) inserted for at least 1 month prior to study entrance
    • Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must adhere to concomitant therapy prohibitions of the test areas and must agree to avoid intense UV exposure of the test areas during the study
    • Written Informed Consent
    E.4Principal exclusion criteria
    • A general medical condition (including underlying dermatological diseases) that in the investigators opinion may confound the study assessments
    • A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial (including but not limited to: serious infectious diseases, major surgery within the last 4 weeks, coronary artery disease, renal impairment, hepatic impairment, cancer, uncontrolled metabolic diseases, autoimmune diseases)
    • Any condition other than atopic dermatitis or treatment that may interfere with the barrier skin function or may lead to dermatitis
    • A condition of the skin in the test area that in the investigators opinion may confound the study assessments (e.g. extensive body hair, scars, tattoos, piercings) or may put the patient at risk (e.g. localized bacterial or viral infection, suspected Tinea, open wounds)
    • The patient has exposed the test areas to excessive UV radiation (or UV therapy) within 1 month prior to baseline or is planning intense UV exposure during the study
    • Very severe atopic dermatitis as measured by the IGA-Score 5 or, in the judgement of the investigator, an indication for a systemic anti-inflammatory therapy
    • An indication for a topic therapy that requires topical treatment anywhere on the body with a corticosteroid more potent than Class II or more than 10 % of the body surface area or any non-corticosteroid anti-inflammatory topical treatment during the study
    • Administration of any systemic drug indicated to treat atopic dermatitis (e.g. steroids, immunosuppressives such as ciclosporine, azathioprine, mycophenolatmofetile; leucotrien antagonists) within 1 month prior to study entry or during the study
    • Systemic administration of antihistamines within 2 weeks prior to study entry and during the study
    • Administration of any topical treatment (e.g. topical steroids, calcineurin inhibitors) in the region of the designated test areas within 2 weeks prior to study entry
    • Administration of any other topical treatment (including cosmetic products) in the region of the designated test areas during the study
    • Presence or history of a malignant skin disease (other than surgically removed basalioma or sufficiently treated actinic keratosis)
    • Presence or history of any malignant disease (other than skin malignancy) in the last 10 years
    • Known adverse reactions of any severity or hypersensitivity to any ingredient of the IMPs (in particular to Prednicarbat)
    • Presence of cutaneous reactions as a result of vaccination
    • Presence of cutaneous manifestation of tuberculosis, of syphilis or of viral infections (e.g. varicella)
    • Presence of rosacea
    • Presence of perioral dermatitis
    • Presence of bacterial or mycotic dermal infections in the test areas
    • Immunotherapy (e.g. allergen desensitisation) prior to and during the study
    • Vaccination within 6 days prior to enrolment in the study and during the study
    • A female patient with a positive urine pregnancy test at baseline (or if retested during the course of the study), is breast-feeding or is planning to become pregnant or breast-feed a child during the study
    • Participation in any other clinical trial within 4 weeks prior or during this trial
    • Patient is an adult under guardianship, deprived of freedom or unable to communicate or cooperate with the Investigator due to language or mental problems
    • Patient is a suspected substance-abuser or is in the opinion of the investigator unreliable or non-compliant
    E.5 End points
    E.5.1Primary end point(s)
    Due to the small sample size, the statistical analysis will be performed on a descriptive level.

    Primary objective is to gain evidence of the safety and local tolerability of Prednicarbat cream/Prednicarbat ointment compared to placebo, assessed by the severity, nature and frequency of AEs/SAEs, vital signs and the relationship to study medication. Tolerability will be assessed by examination of skin reactions after topical application of the IMPs by physician and patient.
    The secondary objectives are to gain evidence of the tolerability and efficacy of Prednicarbat cream/Prednicarbat ointment compared to placebo.
    The patients’ global assessment of tolerability (PaGA) and the physicians’ global assessment of tolerability (PGA) will be assessed at the end of the trial.
    A physical examination will be performed.
    The efficacy is assessed by modified EASI (Modified Eczema Area and Severity Index).
    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 Information not present in EudraCT
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    intraindividual comparison
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    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 state50
    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 Decision2009-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-28
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