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    Summary
    EudraCT Number:2009-016629-33
    Sponsor's Protocol Code Number:H521000-0914
    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:2009-11-20
    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 number2009-016629-33
    A.3Full title of the trial
    A 12 day placebo- and reference-controlled, double-blind, single center, randomized, phase II clinical study with an intraindividual comparison, investigating the anti-psoriatic efficacy and the tolerability of LAS41002 lotion in a psoriasis plaque test
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and tolerability of LAS41002 lotion in a psoriasis plaque test
    A.4.1Sponsor's protocol code numberH521000-0914
    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 SponsorAlmirall Hermal 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 nameLAS41002 lotion
    D.3.2Product code LAS41002 lotion
    D.3.4Pharmaceutical form Cutaneous emulsion
    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.3.9.1CAS number 83919-23-7
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 ECURAL Fettcreme
    D.2.1.1.2Name of the Marketing Authorisation holderEssex Pharma GmbH
    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 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.3.9.1CAS number 83919-23-7
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous emulsion
    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
    Psoriasis vulgaris
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is the clinical examination (visually and by palpating the respective test area) of the reduction of psoriatic lesions: LAS41002 lotion better than (superior to) placebo at study day 12.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    •Clinical examination (visually and by palpating the respective test area) at study day 5, LAS41002 lotion compared to placebo.
    •Clinical examination (visually and by palpating the respective test area) at study days 5 and 12, LAS41002 lotion compared to the reference product Ecural® cream (non-inferiority)
    •Relative changes (given in %) from baseline ultrasound measurements at study day 5 and study day 12: LAS41002 lotion in comparison to placebo and the reference product Ecural® cream

    •Global tolerability of LAS41002 lotion, reference and placebo, assessed at the last study day
    •Clinical (digital) photography at each assessment time point
    •Safety parameters are documented and analyzed during treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •18 to 75 years of age
    •Caucasian men and women (skin type I to IV, Fitzpatrick 1974)
    •Mild to moderate chronic plaque psoriasis
    •At least one stable psoriatic plaque (stable plaque = plaque with no major changes in the size and no new plaque formation within the last two weeks prior screening. Changes in scaling and minor changes in erythema are allowed) in an area sufficient for product application
    •All patients must give written informed consent before any assessment is performed.
    •Psoriasis must be amenable for local therapy
    •Willingness to actively participate in the study and come to scheduled visits
    •Willingness to discontinue the use of cosmetic products (e.g. soaps, creams, moisturizers) in the treatment area throughout the course of the study
    •negative urine pregnancy test (in female patients of child bearing potential)
    •Reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomized partner)
    E.4Principal exclusion criteria
    •Patients who need systemic treatment for their body psoriasis
    •Severe forms of psoriasis and the following forms of psoriasis
    • guttatae
    • punctata
    • erythrodermatica
    • exfoliative
    • arthropathica
    • pustular
    •Widespread chronic stationary psoriasis
    •Changes in the expression of psoriasis within the last 6 weeks prior screening
    •Intensive UV-light exposure within two weeks before the beginning of the test as well as during the study and four weeks after the end of the study at the test area

    •Topical treatment of the test area (see table below):
    Corticosteroids, antibiotics 4 weeks prior to study day 1 and during conduct of study
    Retinoids 6 weeks prior to study day 1 and during conduct of study
    Anti-inflammatory substances 2 weeks prior to study day 1 and during conduct of study
    Vitamin A analogs,
    Vitamin D analogs,
    Immunosuppressants,
    Anthracen derivates 2 weeks prior to study day 1 and during conduct of study
    Salicylic acid preparations During conduct of study
    Tar 2 weeks prior to study day 1 and during conduct of study
    UVB therapy 2 weeks prior to study day 1 and during conduct of study
    PUVA therapy 4 weeks prior to study day 1 and during conduct of study
    Neutral emollients 1 week prior to study day 1 and during conduct of study

    •Topical treatment of all other body regions with corticosteroids or immunosuppressants in case more than 20 % of the body surface area is treated
    •Treatment with any non-marketed drug substance (i.e. an agent which had not yet been made available for clinical use following registration) within 4 weeks prior to study day 1

    •Systemic treatment that may interfere with the investigational product (see table below):
    Corticosteroids, antibiotics 4 weeks prior to study day 1 and during conduct of study
    Retinoids 6 weeks prior to study day 1 and during conduct of study
    Vitamin D supplements, hydroxycarbamide, azathioprine, meth-otrexate, cyclosporine 4 weeks prior to study day 1 and during conduct of study
    Immunomodulators 3 months prior to study day 1 and during conduct of study
    Treatment with biologicals with a possible effect on psoriasis 6 months prior study day 1 and during conduct of study
    Antiphlogistics
    (minor pain relief medicine like acetyl salicylic acid or acetaminophene if not more than 1000 mg per day is allowed) 4 weeks prior to study day 1 and during conduct of study
    Planned initiation of, or changes to concomitant medication that could affect psoriasis (e.g. beta blockers, anti-malaria drugs, lithium) 8 weeks prior to study day 1 and during conduct of study


    •Diseases:
    Specific skin diseases (such as tuberculosis or syphilis)
    Skin infections caused by bacteria or viruses or fungal skin infection
    Varicella zoster
    Skin reactions after immunization
    Rosaceae, perioral dermatitis in test area
    Moderate or severe illness within the last two weeks before first exposure
    Known infectious diseases (e.g. hepatitis or AIDS)
    Other inflammatory skin diseases that may confound the evaluation of psoriasis

    •Known hypersensitivity to any of the study drugs, to ingredients of the study drugs, to drugs of similar chemical classes or to plaster
    •History of malignancy of any organ system
    •Pregnancy or lactation
    •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
    •Any history of drug addiction or alcoholism in the past 3 years
    •Patients with poor compliance
    •Patients, who are inmates of psychiatric wards, prison or state institutions
    •Participation in a clinical trial within the last 30 days prior to the start of this study
    •Patients underlying any other restrictions due to the participation in other tests / test institutes
    •Employees of the study sites or of the Sponsor’s company
    •If in the opinion of the investigator the patient should not participate in the study for any reason
    E.5 End points
    E.5.1Primary end point(s)
    Analysis of superiority of the test product LAS41002 to placebo with respect to clinical examinations (visually and by palpating the respective test area) at study day 12
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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
    End of trial is the last visit of the last patient
    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 months1
    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 months1
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-11-20. Yes
    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 state24
    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 after study termination is not foreseen
    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 Decision2009-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-05
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