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    The EU Clinical Trials Register currently displays   37995   clinical trials with a EudraCT protocol, of which   6234   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-004519-28
    Sponsor's Protocol Code Number:H573000-1307
    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:2013-11-22
    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 number2013-004519-28
    A.3Full title of the trial
    A phase II trial to evaluate the anti-psoriatic efficacy and tolerability of tazarotene in a gel formulation in patients with mild to moderate nail psoriasis - parallel group comparison
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II trial to evaluate the anti-psoriatic efficacy and tolerability of tazarotene in a gel formulation in patients with mild to moderate nail psoriasis - parallel group comparison
    A.4.1Sponsor's protocol code numberH573000-1307
    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 pointClinical Trail Manager
    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 number49040 60 68 97 0
    B.5.5Fax number49 040 60 68 97 30
    B.5.6E-mailwiebke.havemeister@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 nameTazarotene gel 0.1 %
    D.3.2Product code LAS41006
    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 INNTAZAROTENE
    D.3.9.1CAS number 118292-40-3
    D.3.9.2Current sponsor codeLAS41006
    D.3.9.4EV Substance CodeSUB10844MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with mild to moderate nail psoriasis
    E.1.1.1Medical condition in easily understood language
    nail 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
    The primary objective of this trial is to assess the anti-psoriatic efficacy and tolerability of tazarotene in a gel formulation in patients with mild to moderate nail psoriasis compared to the vehicle
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • men and women aged 18 to 75;
    • mild to moderate nail psoriasis on one target fingernail (mNAPSI 12 to 50 inclusive at screening and Day 1);
    • nail growth of the target fingernail of ≥1 mm per month;
    • the physical examination of the skin including nails must be without further disease findings (other than psoriasis) unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
    • subjects with body psoriasis must have chronic, stable, mild to moderate body psoriasis;
    • female volunteers 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 intrauterine devices (IUDs), sexual abstinence or had a vasectomized partner
    • 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 2 years
    E.4Principal exclusion criteria
    • pustular psoriasis;
    • target fingernail thicker than 2 mm at free edge (if necessary, a sliding caliper for measurement of thickness will be used);
    • concomitant onychomycosis of the target fingernail shown by negative culture;
    • any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;
    • history of hypersensitivity to tazarotene or to drugs with similar chemical structures or to other components of the study medication or to the adhesive bandage;
    • topical treatment of nails with antipsoriatics (e.g. topical nail application of corticosteroids, retinoids, vitamin D analogues, 5-fluorouracil or anthralin) in the 4 weeks preceding the treatment phase and during the trial including the 3-month follow-up period;
    • systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial including the 3-month follow-up period with antipsoriatics e.g. retinoids, cytostatics, corticosteroids, immunosuppressive therapy, or biologics, with the exception of ustekinumab, which should not have been taken within the six months prior to the treatment phase or during the trial.);
    • intralesional steroid injection in the nail fold within the three months before the treatment phase of the trial or during the trial;
    • phototherapy (including UVB and PUVA) within three months before the treatment phase of the trial;
    • treatment with systemic or locally acting medications which might counter or influence the trial aim or medications e.g. those which are known to provoke or aggravate psoriasis, such as antimalarial drugs, lithium, beta-blockers and indomethacin within 4 weeks before the treatment phase of the trial and during the trial;
    • any chronic infection or condition capable of interfering with the conduct of the trial;
    • evidence of drug or alcohol abuse;
    • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks preceding the treatment phase of the trial;
    • participation in the treatment phase of another clinical trial within the last 4 weeks prior to first treatment in this clinical trial;
    • pregnancy or nursing;
    • 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, or the patient is an employee of the sponsor;
    • patient is institutionalized because of a legal or regulatory order.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the % change from baseline in mNAPSI of the target fingernail on Day 85. The primary analysis will compare the results for this endpoint for the tazarotene gel 0.1 % (LAS41006) group versus (vs.) the vehicle group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 85
    E.5.2Secondary end point(s)
    The changes in the mNAPSI index after 2, 4 and 8 weeks of application will be evaluated along the lines of the primary analysis to assess the onset of treatment effect.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 2, 4 and 8 weeks of application
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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: 50
    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 state60
    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 Decision2013-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-07
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