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    Summary
    EudraCT Number:2018-004370-96
    Sponsor's Protocol Code Number:LG-TCS-AD
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-17
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-004370-96
    A.3Full title of the trial
    The effects of topical corticosteroid use on insulin sensitivity and bone turnover
    Effekten af binyrebarkhormon lokalbehandling på udvikling af diabetes og knogleskørhed
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of topical corticosteroid use on insulin sensitivity and bone turnover
    Effekten af binyrebarkhormon lokalbehandling på udvikling af diabetes og knogleskørhed
    A.4.1Sponsor's protocol code numberLG-TCS-AD
    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 SponsorJacob Pontoppidan Thyssen
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportInnovation Fund Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAage Bang's Fund
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGentofte Hospital
    B.5.2Functional name of contact pointDepartment of Dermatology
    B.5.3 Address:
    B.5.3.1Street AddressKildegaardsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.6E-maillise.gether.01@regionh.dk
    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 Yes
    D.2.1.1.1Trade name Betnovate (Betamethasone) 0.1% ointment
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline UK
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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
    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 INNBetnovate
    D.3.9.1CAS number 378-44-9
    D.3.9.3Other descriptive nameBETAMETHASONE
    D.3.9.4EV Substance CodeSUB05797MIG
    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) 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 Protopic (Tacrolimus) 0.1 % ointment
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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
    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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.4EV Substance CodeSUB10797MIG
    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) 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 placeboOintment
    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
    Atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic eczema
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We hypothesise that use of TCS elicits insulin resistance and increases bone resorption (indicating increased risk of osteoporosis) in AD patients.
    The aim is, therefore, to explore the adverse systemic drug reactions of TCS. Specifically, we aim to
    1. evaluate whether full-body TCS treatment results in hepatic and/or whole-body insulin resistance (the forerunner of T2D) as well as increased bone resorption (indicating increased risk of osteoporosis) in patients with AD
    2. evaluate the effect of TCS on skin and serum biomarkers of skin barrier function as well as skin microbiome composition
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    • Age 18–75 years
    • AD according to the Hanifin and Rajka Criteria22
    • AD for at least 3 years
    • BMI ≤ 30 kg/m2
    • Haemoglobin A1c (HbA1c) ≤ 42 mmol/mol (6.0%)
    • Normal haemoglobin
    • Informed consent
    E.4Principal exclusion criteria
    Exclusion criteria
    • Diagnosed diabetes mellitus
    • Other chronic inflammatory diseases (including but not limited to rheumatoid arthritis, inflammatory bowel disease etc) beside AD and non-treatment demanding rhinitis or asthma (treated within the last 4 weeks)
    • Pregnancy or breast feeding
    • Treatment with drugs that might affect the glucose metabolism beside TCS within a month prior to the project
    • Daily smoker, alcoholic, or drug abuser
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in whole-body insulin sensitivity during treatment with TCS compared to the control group treated with TCI. Insulin sensitivity will be assessed by the hyperinsulinaemic euglycaemic clamp method with glucose tracer and indirect calorimetry (rate of disappearance (Rd)).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After all patients have completed the study and samples are analysed.
    E.5.2Secondary end point(s)
    Key secondary endpoints are markers of bone resorption and formation including C-terminal telopeptide of type I collagen (CTX), N-terminal propeptide of type 1 procollagen (P1NP) and parathyroid hormone (PTH), respectively, and body composition (assessed by dual-energy X-ray absorptiometry (DXA) scan).

    Other secondary endpoints include differences between patients treated with TCS and TCI controls during basal and insulin-stimulated steady-state in:
    • Glucose oxidation (assessed by indirect calorimetry)
    • Non-oxidative glucose metabolism (NOGM)
    • Endogenous glucose production (calculated from glucose tracer data)
    • Lipid oxidation (assessed by indirect calorimetry)
    • Insulin resistance according to the homeostatic model assessment (HOMA-IR) index
    • Beta cell function (assessed by arginine-stimulation test)

    Differences between patients treated with TCS and TCI matched controls in:
    • Serum/plasma concentrations of insulin, C-peptide, glucagon, free fatty acids (FFA), high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), tumor necrosis factor-α (TNF-α)
    • Liver status (assessed by plasma levels of transaminases and fibro scanning)
    • Assessment of internal corticosteroid exposure by urine sampling and skin tape striping that will undergo analysis with high-performance liquid chromatography (HPLC).
    • Skin barrier status and possible differential improvement and effects (assessed using skin tape strip analysis for amino acids (filaggrin degradation products), and inflammatory biomarkers of relevance to AD (including but not limited to CCL-17, IL-1, IL-4, IL-13, IL-22)
    • Analysis of T-cell phenotype by flow cytometry and single cell sequencing
    • Microbiome analysis: Investigation of different treatment effects on the composition of skin bacteria (assessed using skin and nasal swaps for sequencing bacterial microbiome DNA)
    • AD severity (evaluated by VAS for itch intensity and sleep disturbance, EASI, DLQI, POEM
    • Transepidermal water loss
    • Level of physical activity (assessed by IPAQ)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After all patients have completed the study and blood, urine and skin samples are analysed.
    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 No
    E.6.5Efficacy No
    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
    Side effects from full-body topical corticosteroid treatment.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 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 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
    When 36 patients have completed the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 36
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state36
    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)
    None
    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 Decision2019-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-15
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