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    Summary
    EudraCT Number:2020-000252-35
    Sponsor's Protocol Code Number:DA-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:2020-02-11
    Trial 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 number2020-000252-35
    A.3Full title of the trial
    The risk of an elevated intraocular pressure after treatment with topical corticosteroids in the periocular region
    Risikoen for intraokulær trykstigning efter behandling med topikale kortikosteroider periokulært
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The risk of an increased eye pressure after treatment with steroid cream around the eye
    Risikoen for øget øjentryk efter behandling med binyrebarkhormoncreme i øjenomgivelserne
    A.4.1Sponsor's protocol code numberDA-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 SponsorLone Skov
    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 supportNone as of yet
    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 AddressGentofte Hospitalsvej 15, 1. floor
    B.5.3.2Town/ cityGentofte
    B.5.3.3Post code2820
    B.5.3.4CountryDenmark
    B.5.6E-maildiva.amiri@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 Locoid Lipid 0.1 % cream
    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 Cream
    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 INNHYDROCORTISONE BUTYRATE
    D.3.9.1CAS number 13609-67-1
    D.3.9.4EV Substance CodeSUB02563MIG
    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 Mildison Lipid 1% cream
    D.2.1.1.2Name of the Marketing Authorisation holderKaro Pharma
    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 Cream
    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 INNHydrocortisone
    D.3.9.3Other descriptive nameHYDROCORTISONE
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Intraocular pressure in healthy individuals and in patients with atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    Intraocular pressure: Fluid pressure inside the eye
    Atopic dermatitis: 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022801
    E.1.2Term Intraocular pressure
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate whether daily treatment with topical corticosteroids in the periocular region causes a change in comparison to the control group.
    Det primære formål med studiet er at vurdere, hvorvidt daglig behandling med topikale kortikosteroider i den periokulære region medfører en ændring i det intraokulære tryk, sammenlignet med kontrolgruppen.
    E.2.2Secondary objectives of the trial
    Duration of treatment (number of days) with topical corticosteroids prior to a measurable increase in intraocular pressure and a potential dose-dependent variation thereof.
    Viden om behandlingsvarighed (antal dage) med topikale kortikosteroider forinden en eventuel stigning i det intraokulære tryk samt en dosisafhængig variation heraf.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age: 18-75 years
    BMI: <30 kg/m2
    Signed consent

    Only relevant for patients with atopic dermatitis:
    Known atopic dermatitis, assessed by EASI (Eczema Area and Severity Index) and TLSS (Target Lesion Severity Score)
    Alder: 18-75 år
    BMI: <30 kg/m2
    Skriftligt underskrevet samtykke

    Kun relevant for AD-patienter:
    Kendt atopisk dermatitis, vurderet med EASI (Eczema Area and Severity Index) og TLSS (Target Lesion Severity Score).
    E.4Principal exclusion criteria
    Medical history of an eye disease that requires treatment with corticosteroids, including inflammatory eye diseases, such as iritis.

    Treatment with previous drugs that contains corticosteroid (within the last 4 weeks).

    Allergy towards the ingredients in the drugs administered during the trial.

    Diagnosed diseases that may affect or can be affected by the trial/treatment. These include untreated infections, acne vulgaris, rosacea, perioral dermatitis and malignant/premalignant lesions.

    Pregnancy.
    Anamnese med kortikosteroid-behandlingskrævende øjensygdom, herunder inflammatoriske øjensygdomme, såsom regnbuehindebetændelse.

    Behandling med foregående lægemidler, der indeholder kortikosteroid (indenfor de sidste 4 uger).

    Allergi overfor indholdsstofferne i forsøgsmedicinen.

    Diagnosticeret sygdomme, der muligvis påvirker eller påvirkes af studiet/behandlingen. Disse inkluderer ubehandlede infektioner, acne vulgaris, rosacea, perioral dermatitis og maligne/præmaligne læsioner.

    Graviditet.
    E.5 End points
    E.5.1Primary end point(s)
    Total change in intraocular pressure measured with 'Icare ic100 tonometer' at two, three and four weeks following introduction of the topical corticosteroids treatment.
    Total ændring i intraokulært tryk målt ved brug af 'Icare ic100 tonometer' to, tre og fire uger efter initiering af behandling med topikale kortikosteroider.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14, 21 and 28 days
    14, 21 og 28 dage
    E.5.2Secondary end point(s)
    Duration of treatment (number of days) with topical corticosteroids prior to a measurable increase in intraocular pressure and a potential dose-dependent variation thereof.
    Viden om behandlingsvarighed (antal dage) med topikale kortikosteroider forinden en eventuel stigning i det intraokulære tryk samt en dosisafhængig variation heraf.
    E.5.2.1Timepoint(s) of evaluation of this end point
    14, 21 and 28 days
    14, 21 og 28 dage
    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
    The study will involve research in the adverse drug reactions reported in relation to the IMPs
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 26 healthy individuals and 16 patients with atopic dermatitis have completed the study.
    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 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: 42
    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 Yes
    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 state42
    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 Decision2020-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-31
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