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    Summary
    EudraCT Number:2009-012063-33
    Sponsor's Protocol Code Number:H 569 000-0908
    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:2009-06-02
    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 number2009-012063-33
    A.3Full title of the trial
    Double-blind, randomized, multi-centre phase II study to evaluate the efficacy and safety of topically applied LAS41007 once daily and LAS41007 twice daily versus Solaraze® 3% gel twice daily in the treatment of actinic keratosis grade I to II
    A.3.2Name or abbreviated title of the trial where available
    LAS41007
    A.4.1Sponsor's protocol code numberH 569 000-0908
    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 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 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.3.2Product code LAS41007 (5% diclofenac gel)
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDICLOFENAC SODIUM
    D.3.9.1CAS number 15307796
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 Solaraze 3% gel
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Almirall. S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSolaraze® 3% gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDICLOFENAC SODIUM
    D.3.9.1CAS number 15307796
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    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 aged 18 and older suffering from actinic keratoses. Patients to be considered have at least four and up to ten actinic keratoses of grade I to grade II in two treatment blocks of 25 cm2 each within the face/forehead (excluding eyelids, lips and mucosa) or bald scalp.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    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 study objectives are to compare the efficacy of 5% diclofenac gel twice daily to Solaraze® 3% gel twice daily, assessed by histology (according to Röwert-Huber, 2007) to evaluate the clearance of one pre-selected target lesion at 30 days post-treatment (PT, Visit 8), and assessed by actinic keratosis lesion count (using the target lesion number score (TLNS)) to evaluate the complete clinical clearance (indicated by TLNS = 0) of all target lesions in the treatment area at 30 days PT (Visit 8).
    E.2.2Secondary objectives of the trial
    A secondary study objective is to compare the efficacy of 5% diclofenac gel once daily to Solaraze® 3% gel twice daily, measured by the same primary efficacy variables, as stated for the primary objectives.
    A further secondary objective is to compare the efficacy of 5% diclofenac gel twice daily to Solaraze® 3% gel twice daily with regard to a decreased time to complete clinical clearance, assessed by actinic keratosis lesion count (TLNS) to evaluate the complete clinical clearance (indicated by TLNS = 0) at each visit during the treatment (Visit 3 - Visit 7) following Baseline (Visit 2).

    Further secondary objectives are to assess the safety and tolerability of 5% diclofenac gel, either applied once daily or twice daily compared to Solaraze® 3% applied twice daily. Patient's compliance will also be controlled.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - caucasian male and female patients prepared and able to give written informed consent
    - physical ability to comply to the study preparations correctly and to follow the study restrictions and visits
    - ages eligible for study: 18 years and older
    - Actinic keratoses (AK) with a diameter of 0,5 to 1.5 cm, that are definitively distinguished from other lesions and display a minimum distance of 1 cm to neighbored lesions. The AK lesions to be treated, at least four but not more than 10, need to be of mild to moderate intensity (grade I to grade II) and located in overall two treatment blocks with a size 25 cm2 each, within the face/forehead (excluding eyelids, lips and mucosa) or bald scalp. For histological confirmation (of clearance) of the AK diagnosis a pre- and post-treatment punch biopsy is taken.
    - women of childbearing potential will not be considered unless they use a highly effective method of contraception (failure rate of less than 1% per year)
    E.4Principal exclusion criteria
    - Have known hypersensitivity, intolerance or allergies against diclofenac sodium or other ingredients of the investigational medicinalproducts and other non-steroidal antirheumatic agents.
    - Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
    - Have a history of gastrointestinal bleeding or perforation associated with prior therapy with NSAIDs.
    - Have evidence of clinically significant or unstable medical conditions such as: (a) metastatic tumor or tumor with high probability of metastatic spread, (b) heart failure (NYHA class III or higher), (c) immunosuppressive disorder (e.g. HIV), (d) hematologic, hepatic, renal, neurologic or endocrine disorder, (e) collagen-vascular disorder (e.g. cerebro-vascular disorder or other bleedings), (f) gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage).
    - Within the treatment areas other malignant or benign skin tumors, Cornu cutaneum and/or hypertrophic AK lesions are observed.
    - Any clinically relevant abnormal finding regarding the laboratory assessment performed at Screening (only applicable for two study centers; to be reviewed at baseline).
    - Suffer from paresthesia in the treatment areas.
    - Within 6 weeks prior to Day 1 and throughout the study topical treatment in the target area(s) with topical preparations containing retinoids, steroids, 5-fluorouracil or topical immunomodulators.
    - Within 6 weeks prior to Day 1 and throughout the study, topical treatment in the target area(s) with diclofenac preparations other than the investigational medicinal product(s) (IMPs).
    - Throughout the study, topical treatments with diclofenac preparations outside the target area are prohibited. Exception: if needed only occasionally and not as permanent therapy (pro re nata, ≤ 3 days at a strech; e.g. Voltaren® Emulgel).
    - Within 6 weeks prior to Day 1 and throughout the study, systemic treatment with diclofenac.
    - Within 6 months prior to Day 1 and throughout the study, systemic treatment with retinoids, interferon, cytotoxic drugs.
    - Within 3 months prior to Day 1 and throughout the study, systemic treatment with 5-fluorouracil preparations, drugs known to have major organ toxicity and immunomodulators or immunosuppressive therapies.
    - Within 4 weeks prior to Day 1 and throughout the study, systemic treatment with oral, injectable corticosteroids. The same applies for inhaled corticosteroids, if the daily dose for beclomethasone exceeds 1200 µg/day or 600 µg/day for fluticasone.
    - Physical treatments in the treatment areas such as surgical excision (except biopsy for diagnostic confirmation), cryo-, thermo- or chemodestruction and photodynamic therapy within 6 weeks prior to Day 1 and throughout the study.
    - Curettage in the treatment areas within 4 weeks prior to Day 1 and throughout the study.
    - Patients who need a permanent therapy with any other NSAID. The use of NSAIDs as “prn” (pro re nata), i.e. to be taken as needed (≤ 3 days at a stretch) and the use of ASA as anticoagulative therapy (see below) will be allowed.
    - Patients taking methotrexate or sulfonylurea.
    - Anticoagulative therapy with Marcumar throughout the study. Treatment with ASA at a dose not exceeding 100 mg/d and clopidogrel at a dose not exceeding 75 mg/d will be allowed.
    - Patients having any significant physical abnormalities in the potential treatment areas that may cause difficulty with examination or final evaluation.
    - Patients not willing to abstain from sunbathing (including solarium) or any outdoor activities with intensive sun exposure without taking appropriate measures to cover the treatment areas during the study.
    - Are not willing to stop the use of sunscreens and make-ups in the treatment areas approximately 48 hours before a study visit with lesion count.
    - Patients not willing to stop using skin care products (e.g. topical treatments with anti-aging products, vitamin A, vitamin C, and/or vitamin E containing ointments and gels, and green tea preparations), except sunscreens and make-ups during the study within the treatment area.
    - Have any dermatological disease in the treatment areas or surrounding area that may be exacerbated by treatment with topical diclofenac or cause difficulty with examination (e.g. psoriasis, eczema, dermatitis exfoliativa).
    - Pregnant or breast-feeding.
    - Are currently or within the past 8 weeks participating in another clinical study
    - Any suspicion of current drug and/or alcohol abuse
    - Patient is institutionalized because of legal or regulatory order.
    - Employee of the study site or of the Sponsor’s company.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study objective to compare the efficacy of 5% diclofenac gel twice daily to Solaraze® 3% gel twice daily, measured by complete clinical clearance (indicated by Total Lesion Number Score = 0) as well as by histological clearance of one pre-selected target lesion at 30 days PT.
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned7
    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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months8
    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 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 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2009-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-25
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