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    Summary
    EudraCT Number:2013-000715-25
    Sponsor's Protocol Code Number:6520-9170-07
    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:2013-04-26
    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 number2013-000715-25
    A.3Full title of the trial
    A multi-center, randomized, double-blind, phase II trial with intraindividual comparison to assess superiority of Soventol HydroCort 1% cream versus vehicle on lesional skin in patients with mild atopic eczema, seborrheic eczema or stasis dermatitis and to assess safety of Soventol HydroCort 1% cream
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of defined skin parameters in two comparable lesional skin areas after topical treatment with Soventol HydroCort 1% cream or vehicle
    A.4.1Sponsor's protocol code number6520-9170-07
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMEDICE Arzneimittel Pütter GmbH & Co.KG
    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 supportMEDICE Arzneimittel Pütter GmbH & CO.KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationbioskin GmbH
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressBurchardstrasse 17
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20095
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)40606 897 55
    B.5.5Fax number+49(0)40606 89730
    B.5.6E-mailbetina.vanfuerden@bioskin.de
    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 nameSoventol HydroCort 1% cream
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    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.3.9.3Other descriptive nameHYDROCORTISONE
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    manifest atopic dermatitis diagnosed according to Hanifin and Rajka, or seborrheic eczema or stasis dermatitis
    E.1.1.1Medical condition in easily understood language
    patients with atopic dermatitis, seborrheic eczema or stasis dermatitis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10041955
    E.1.2Term Stasis dermatitis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10062813
    E.1.2Term Seborrheic eczema
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10003641
    E.1.2Term Atopic eczema
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the superiority of Soventol HydroCort 1% cream versus vehicle and to assess safety of Soventol HydroCort 1% cream
    E.2.2Secondary objectives of the trial
    Clinical assessment of edema/papulation, oozing/crusting, excoriations, scaling and lichenification will be evaluated descriptively following the primary analysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • men and women aged 18 years or older;
    • manifest atopic dermatitis diagnosed according to Hanifin and Rajka, or seborrheic eczema or stasis dermatitis;
    • two comparable lesional areas of at least 2 cm2, with the clinical condition of atopic eczema or seborrheic eczema or stasis dermatitis rated mild;
    • the lesions should be located contralaterally for patients with atopic eczema and stasis dermatitis;
    • an erythema score ≥ 1 in both lesional areas;
    • the physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;
    • female patients of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
    • written informed consent obtained.
    E.4Principal exclusion criteria
    • acne, suntan, eczema other than atopic eczema, seborrheic eczema or stasis dermatitis massive hyper- or hypopigmentation or tattoos in the treatment areas;
    • syphilitic or tuberculous dermatitis, varicella or vaccine reactions;
    • dark-skinned persons whose skin color prevents ready assessment of skin reactions;
    • evidence of drug or alcohol abuse;
    • pregnancy or nursing;
    • UV-therapy within 6 weeks before first treatment;
    • symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial;
    • participation in the treatment phase of another clinical trial within the last four weeks prior to the first administration of investigational drug in this clinical trial;
    • known allergic reactions to components of the investigational product/s;
    • treatment with systemic or locally acting medications which might counter or influence the trial aim within four weeks before the baseline visit and during the trial, e.g. antihistamines, medication that influences liver function, or glucocorticosteroids (exception: asthma may be found in patients with atopic dermatitis, therefore inhalation with corticosteroids in patients with asthma accompanying atopic dermatitis will be allowed);
    • contraindications according to the summary of product characteristics of Soventol® HydroCort 0.5% and Linolacort® Hydro 1.0%;
    • in the opinion of the investigator or physician performing the initial examination the patient should not participate in the clinical trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
    • close affiliation with the investigator (e.g. a close relative) or persons working at the trial centers or patient is an employee of sponsor;
    • patient is institutionalized because of legal or regulatory order.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the superiority of IMP versus vehicle with respect to the AUC of baseline corrected erythema scores.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AUC is determined over the whole experimental phase.
    E.5.2Secondary end point(s)
    Clinical assessment of edema/papulation, oozing/crusting, excoriations, scaling and lichenification will be evaluated descriptively.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The clinical assessments will be presented descriptively by visit.
    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 No
    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 No
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    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 No
    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 end of the trial is defined as the last visit of the last patient completing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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
    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 further treatment is not intended.
    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 Decision2013-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-26
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