Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-002583-80
    Sponsor's Protocol Code Number:38814
    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:2013-09-06
    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 number2013-002583-80
    A.3Full title of the trial
    Treatment of Actinic Keratoses with Ingenol Mebutate and topical glucocorticosteroid - a safety study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Actinic Keratoses with Ingenol Mebutate and topical glucocorticosteroid - a safety study
    A.4.1Sponsor's protocol code number38814
    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 SponsorDepartment of Dermatology, Bispebjerg University Hospital
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Dermatology, Bispebjerg University Hospital
    B.5.2Functional name of contact pointClinical Trail Information
    B.5.3 Address:
    B.5.3.1Street AddressBispebjerg Hospital,
    B.5.3.2Town/ cityCopenhagen NV
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4560668830
    B.5.6E-mailandres.erlendsson@gmail.com
    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 Picato®
    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 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 INNINGENOL MEBUTATE
    D.3.9.3Other descriptive nameINGENOL MEBUTATE
    D.3.9.4EV Substance CodeSUB32495
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.015
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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 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 Dermovat
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDermovat 0.5%®
    D.3.4Pharmaceutical form Cream
    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 INNCLOBETASOL PROPIONATE
    D.3.9.3Other descriptive nameCLOBETASOL PROPIONATE
    D.3.9.4EV Substance CodeSUB01346MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    Actinic Keratoses
    E.1.1.1Medical condition in easily understood language
    Solar Keratoses
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is to investigate whether local skin responses seen after Picato® can be treated with a topical glucocorticosteroid. Secondary objective is to investigate if the treatment efficacy is affected by it. It is the perspective of this study to be offer patients safe treatment of local skin responses after Picato® treatment while maintaining an effective eradication of the Actinic Keratoses.
    E.2.2Secondary objectives of the trial
    Evaluate if patient satisfaction as well as short and long term side effects (hyperpigmentation, hypopigmentation and scarring) are affected by the use of a topical glucocorticosteroid after Picato® treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18 or older
    • Two eligible areas of 25 cm2 containing 4-20 AK lesions in the face or two eligible areas of 25 cm2 containing 4-20 AK lesions in the scalp
    • Minimally four lesions in every area are Grade I or II (Grade I: Thin lesions, are better felt than seen, Grade II: Moderately thick, are easily seen and felt, Grade III Very thick and/or hyperkeratotik lesions)
    • Fertile women must document non-reactive urine pregnancy test at the day of inclusion
    • During the study fertile women must be using effective birth control. Effective contraception is defined as follows:
    o Injectable or implantable hormones;
    o Intrauterine device;
    o Trans-abdominal surgical sterilization;
    o Sterilization implant device;
    o Surgical sterilization of male partner;
    o Complete abstinence from sexual intercourse for two weeks before exposure to study medication and throughout the clinical study
    • Verbal and written consent to participate in the study
    • Documentation of the medicine status
    E.4Principal exclusion criteria
    • Non-melanoma skin cancer, Mb. Bowen or keratoacanthoma in the treatment area
    • Previously treated with Ingenol Mebutate in the treatment area
    • Tattoos, moles, or other active dermatological condition in the treatment area
    • History of Psoriasis
    • Medication with a systemic immunosuppressive, cytotoxic, immune modulating or retinoid agent within the last 3 months
    • Use of topical applicants in the treated area that could interfere with the treatment or evaluation of the treatment the first 14 days, including commercially available day and night crèmes with retinoid agents
    • Pregnant and breastfeeding women
    • Patients that are considered incapable of complying with the protocol, i.e. patients suffering from dementia, alcoholism or psychiatric conditions
    E.5 End points
    E.5.1Primary end point(s)
    Local skin reactions (LSR), clinical evaluation.
    Blinded clinical evaluation by a physician. The LSR Grading Scale is used to graduate Erythema 0-4, Flaking/Scaling 0-4, Crusting 0-4, Swelling 0-4, Vesiculation/Pustulation 0-4, Erosion/Ulceration 0-4. The scores are added for each patient, giving a maximum of 24 and a minimum of 0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 1, 4, 8, 15 and 57 after treatment with Picato®
    E.5.2Secondary end point(s)
    1. Efficacy, day 15 and 57.
    a. Number of cleared AK's
    b. Complete clearance of the AK's in the field
    c. Partial clearance, >75% reduction in number of the AK's in the field
    d. Median reduction in the number of cleared AK's in the field
    e. New AKs
    All efficacy measures will be clinically evaluated by a blinded Dermatologist. The initial template is used to evaluate clearance of every original lesion. If not cleared, the grade of the remaining lesion is registered.
    2. Photographic documentation of LSR and treatment effect, day 1, 4, 8, 15 and 57.
    At baseline and follow-up visits, LSR and clinical treatment effects will be photographically documented.
    3. Reflectance at day 1,4,8,15 and 57 (Optimizer)
    The Optimizer is used to evaluate reflectance including Pigment protection factor, Pigmentation, Erythema, Green reflection and red reflection. The measures are aimed at the background skin in the center area and repeated three times, the median value is used.
    4. Delayed side effects at day 15 and 57.
    Blinded clinical evaluation by a dermatologist. All treatment areas will be evaluated for hypopigmentation (0-3), hyperpigmentation (0-3) and scarring (0-2).
    5. Patient satisfaction at day 15 and 57.
    The treating physician will ask the patient which one of the two treatments that was most satisfactory.
    6. Pain and prutitus day 1-15
    The patient will be asked to daily score LSR, pain and prutitus associated with the treatments in a patient diary. LSR are evaluated as "worse", "unchanged" or "better" compared to the day before. Every day the patient is asked if LSR are back to baseline. Pain is evaluated using a visual analog scale 0-10 and pruritus, 1-4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Defined in E.5.2
    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 Yes
    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) 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 Yes
    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
    Intraindividual control
    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
    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 months5
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 21
    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)
    If the treatment fails or is estimated to be insufficient at day 57, the patient will be offered a follow up consultation and treatment according to national guidelines.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Hudklinikken på Jaegersborg Alle
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-28
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 14:56:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA