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    Summary
    EudraCT Number:2013-003757-22
    Sponsor's Protocol Code Number:H553000-1309
    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:2014-01-22
    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 number2013-003757-22
    A.3Full title of the trial
    A phase IIa, 28-day treatment, multi-center, randomized, comparator-controlled, observer-blind trial with intra-individual left/right comparison to investigate the anti-psoriatic efficacy and the safety of an LAS41004 formulation in comparison to an active reference in patients with mild to moderate plaque psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase IIa, 28-day treatment, multi-center, randomized, comparator-controlled, observer-blind trial with intra-individual left/right comparison to investigate the anti-psoriatic efficacy and the safety of an LAS41004 formulation in comparison to an active reference in patients with mild to moderate plaque psoriasis
    A.4.1Sponsor's protocol code numberH553000-1309
    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 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 supportAlmirall Hermal GmbH
    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 pointWiebke Havemeister, PhD
    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+4904060689735
    B.5.5Fax number+4904060689730
    B.5.6E-mailwiebke.havemeister@bioskincro.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 nameLAS 41004
    D.3.2Product code LAS 41004
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEXAROTENE
    D.3.9.1CAS number 153559-49-0
    D.3.9.4EV Substance CodeSUB00795MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameBETAMETHASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00783MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.064
    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.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 Daivobet® ointment
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    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.3.1Product nameDaivobet® ointment
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCALCIPOTRIOL
    D.3.9.1CAS number 112828-00-9
    D.3.9.4EV Substance CodeSUB06046MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameBETAMETHASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00783MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.0643
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with moderate stable chronic plaque-type psoriasis
    E.1.1.1Medical condition in easily understood language
    psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    To assess the anti-psoriatic efficacy and safety of the combination of BX plus BDP in a topical formulation and by reference to Daivobet® ointment (calcipotriol plus BDP).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •men or women aged 18 years or older;
    •mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 – 300 cm² and a TSS of ≥ 6;
    •the physical examination paying particular attention to the application area must be without further disease findings (other than psoriasis) unless the investigator considers an abnormality to be irrelevant to the outcome of the trial;
    •female volunteers of childbearing potential* must agree to use for one month prior to start of IMP application, during the trial and for at least one month after EoT reliable methods of contraception with a failure rate of less than 1 % per year (e.g. contraceptive implants of injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner). During the trial an additional barrier method (e.g. condoms) must be used. In the case of men with partners of childbearing potential* willingness of using condoms during the study conduct and for 1 month after end of treatment.
    •written informed consent obtained.
    * Females NOT of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least two years)
    E.4Principal exclusion criteria
    •severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis, including:
    -erythrodermic, exfoliative or pustular psoriasis;
    -psoriatic arthritis;
    -unstable psoriasis, with a change in severity within the last 6 weeks prior screening;
    •treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial;
    •treatment with any systemic medications which might counter or influence the trial aim (including anti-psoriatics like corticosteroids, cytostatics or medications which are known to provoke or aggravate psoriasis (e.g. ß-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial;
    •treatment with vitamin A supplements;
    •treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months;
    •treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial;
    •known allergic reactions, irritations or hypersensitivity to the active ingredients (BX, BDP or calcipotriol) or any other ingredient of the IMPs;
    •contraindications according to summary of product characteristics (SmPC) of the active comparator:
    -hypersensitivity against the substance or to any of the excipients;
    -erythrodermic, exfoliative and pustular psoriasis
    -virus-induced skin lesions (e.g. herpes, varicella)
    -known calcium metabolism disorders;
    -viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections;
    -skin manifestations in relation to tuberculosis or syphilis;
    -perioral dermatitis;
    -atrophic skin, striae atrophicae;
    -fragility of skin veins;
    -ichthyosis;
    -acne vulgaris;
    -rosacea;
    -ulcers;
    -wounds;
    -perianal and genital pruritus.
    •concomitant use of ketoconazole, itraconazole, erythromycin, grapefruit juice or gemfibrozil or application of products that contain DEET (N,N-diethyl-m-toluamide);
    •evidence of drug or alcohol abuse;
    •pregnancy or nursing;
    •symptoms of a clinically significant illness that may influence the outcome of the trial in the 4 weeks before first treatment and during the trial;
    •vaccination within the 6 days prior to the trial;
    •history of malignancy of any organ system (less than 5 years ago);
    •participation in the treatment phase of another clinical trial within the last 4 weeks prior to the first administration of IMPs in this clinical trial or during the trial;
    •in the opinion of the investigator or physician performing the initial examination the patient should not participate in the 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 bioskin GmbH, the other sites or for the sponsor;
    •patient is institutionalized because of legal or regulatory order.
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is the total sign score (TSS) defined as the sum of individual scores for erythema, scaling and infiltration using a 5-point scale (0 = absent, 1 = slight, 2 = moderate,
    3 = severe, 4 = severest possible) for each sign clinically assessed (visually and, where relevant, by palpating the test area).
    The primary endpoint is the change from baseline in the TSS of each treated plaque on Day 29 (EoT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    E.5.2Secondary end point(s)
    •Changes from baseline in the TSS on Days 4, 8, 15, and 22 will be evaluated for each treated plaque in a similar way to the primary analysis to assess the onset of treatment effect
    •Summary statistics will be given for the primary variable TSS and its changes from baseline by treatment and visit for each site.
    All the following secondary endpoints will be summarized descriptively by treatment:
    •Changes from baseline in the score for each of the individual signs (erythema, scaling and infiltration) of each treated plaque on Days 4, 8, 15, 22 and 29
    •Physician’s global assessment (PGA) score of each treated plaque on Days 1, 4, 8, 15, 22 and 29
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 4, 8, 15, 22 and 29
    PGA Days 1, 4, 8, 15, 22, 29
    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 No
    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
    observerblind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 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 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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    No further treatment is 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 Decision2014-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-13
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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