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    Summary
    EudraCT Number:2007-005501-22
    Sponsor's Protocol Code Number:LEO 80190-O23
    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:2008-01-14
    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 number2007-005501-22
    A.3Full title of the trial
    Effect of Calcipotriol Plus Hydrocortisone Ointment on the HPA Axis and Calcium Metabolism in Patients with Psoriasis Vulgaris on the Face and on the Intertriginous Areas
    A.4.1Sponsor's protocol code numberLEO 80190-O23
    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 SponsorLEO Pharma A/S
    B.1.3.4CountryDenmark
    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 namecalcipotriol 25 mcg/g plus hydrocortisone 10 mg/g
    D.3.2Product code LEO 80190 ointment
    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 INNcalcipotriol
    D.3.9.1CAS number 147657-22-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhydrocortisone
    D.3.9.1CAS number 50-23-7
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis vulgaris on the face and on the intertriginous areas.

    The face is defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus).
    In case of baldness or partial baldness, the forehead should be estimated considering standard or previous hairline.


    Intertriginous areas are defined as: 1) the axillae 2) the genito-femoral and inguinal folds 3) the inframammary folds 4) the intergluteal folds and 5) the scrotum.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    To evaluate the effect of once daily use of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment on the hypothalamic-pituitary-adrenal (HPA) axis in patients with psoriasis vulgaris on the face and on the intertrigi-nous areas.

    To evaluate the effect of once daily use of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment on the calcium metabolism in patients with psoriasis on the face and on the intertriginous areas.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and efficacy of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed informed consent has been obtained.

    Clinical diagnosis of psoriasis vulgaris involving the face and the intertriginous areas.

    Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs.

    An extent of the psoriatic involvement on the face of at least 10 cm² (the sum of all facial lesions) and on the intertriginous areas of at least 20 cm² (the sum of all intertriginous areas) at the Baseline Visit and Visit 1.

    Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 100 g of study medication per week.

    Disease severity of the face and of the intertriginous areas graded as moderate, severe or very severe according to the investigator’s global assessment of disease severity at the Baseline Visit and Visit 1.

    Patients with a normal HPA axis function at the Baseline Visit including:
    •serum cortisol concentration above 5 mcg/dl before ACTH (tetracosactid) injection,
    •serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH (tetracosactid) stimulation.

    Albumin corrected serum calcium at the Baseline Visit within the reference range.

    Age 18 years or above.

    Either sex.

    Any race and ethnic origin.

    Females of childbearing potential must have a negative result of a pregnancy test performed at the Screening Visit and at the Baseline Visit.

    Female subjects of child bearing potential have to agree to use a highly effective method of birth control with a failure rate of less than 1% for the clinical study; acceptable are double barrier methods (e.g. cervical cap plus male condom), intra-uterine devices (IUD), surgical sterilization (e.g. documented hysterectomy or tubal ligation), abstinence from intercourse (beginning latest 2 weeks prior to first application of IMP), male sexual partner is sterilized (at least 3 months prior to first application of IMP) and hormonal contraception based on progestin-only formulations (injectables or implants only). Lactating women and use of hormonal contraception on estrogen-basis are not allowed.

    Able to communicate well with the investigator, to understand and comply with the requirements of the study.
    E.4Principal exclusion criteria
    A history of active allergy (except for pollinosis), asthma, allergic skin rash, or sensitivity to any medication (including ACTH, tetracosactid) or to any component of the formulations being tested.

    Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., vitamin D analogues, retinoids, immunosuppressants) within 2 weeks prior to Visit 1.

    Systemic treatment with corticosteroids (including inhaled) within 12 weeks prior to Visit 1.

    Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to Visit 1.

    PUVA therapy or Grenz ray therapy within 4 weeks prior to Visit 1.

    UVB therapy within 2 weeks prior to Visit 1.

    Topical treatment of the face, trunk/limbs or the scalp with topical WHO group 2, 3 and 4 corticosteroids within 4 weeks prior to Visit 1.

    Topical treatment of the face, trunk/limbs or the scalp with topical WHO group 1 corticosteroids within 2 weeks prior to Visit 1.

    Any topical treatment of the face or the intertriginous areas (except for emollients) within 2 weeks prior to Visit 1.

    Unwilling to avoid treatment for the duration of the study with topical corticosteroids.

    Initiation of or expected changes in concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium, ACE inhibitors) during the study.

    Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis.

    Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds.

    Other inflammatory skin diseases (e.g., seborrhoiec dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face or on the intertriginous areas.

    Planned exposure to sun, UVA or UVB during the study that may affect the psoriasis vulgaris.

    Oestrogen therapy or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to Visit 1.

    Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to Visit 1.

    Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole) within 4 weeks prior to Visit 1.

    Hypoglycemic sulfonamides within 4 weeks prior to Visit 1.

    Antidepressive medications within 4 weeks prior to Visit 1.

    Clinical signs or symptoms of Cushing’s disease or Addison’s disease.

    Known or suspected severe renal insufficiency or severe hepatic disorders.

    Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

    Known or suspected endocrine disorder that may affect the results of the ACTH challenge test.

    Known or suspected hypersensitivity to component(s) of the investigational products.

    Patients with diabetes mellitus.

    Irregular sleep schedules.

    Any clinically significant abnormality following review of screening biochemistry/haematology (blood and urine samples) and full physical examination.

    Current participation in any other interventional clinical study.

    Patients who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to enrolment or longer, if the class of substance required a longer washout as defined above (e.g., biological treatments).

    Previously included in this study.

    Patients known or suspected of not being able to comply with the trial protocol (e.g., alcoholism, drug dependency or psychotic state).

    Females who are pregnant, or of childbearing potential and wishing to become pregnant during the study, or who are breastfeeding.

    Positive Hepatitis B, Hepatitis C or HIV test.

    Vulnerable persons (e.g. persons kept in detention under jurisdictional or regulatory
    ruling).
    E.5 End points
    E.5.1Primary end point(s)
    The adrenal response to the ACTH challenge test defined as the serum cortisol concentration obtained after 30 and 60 minutes at Week 4 and Week 8.

    Change in albumin corrected serum calcium from baseline to Weeks 4 and 8 and end of treatment.
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 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 2008-01-14. 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 30
    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 Decision2008-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-08
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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