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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-022244-20
    Sponsor's Protocol Code Number:H 569 000 – 1004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-18
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-022244-20
    A.3Full title of the trial
    Double-blind, randomized, vehicle- and comparator-controlled, multicenter trial to evaluate the efficacy and safety of LAS41007 in the treatment of actinic keratosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to evaluate whether a 5 % diclofenac gel formula is effective and safe to use for treating actinic keratosis;
    tested in comparison to a standard treatment (gel) and a 'placebo' gel; conducted by numerous practises / hosptitals, and in a fashion that neither doctor nor patient knows who receives the new treatment, the standard treatment, and the placebo treatment.
    A.3.2Name or abbreviated title of the trial where available
    LAS41007 Phase III
    A.4.1Sponsor's protocol code numberH 569 000 – 1004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01265602
    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 SponsorAlmirall S.A.
    B.1.3.4CountrySpain
    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 supportAlmirall S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlmirall Hermal GmbH
    B.5.2Functional name of contact pointClinical Project Leader
    B.5.3 Address:
    B.5.3.1Street AddressScholtzstraße 3
    B.5.3.2Town/ cityReinbek
    B.5.3.3Post code21465
    B.5.3.4CountryGermany
    B.5.4Telephone number+4940727 04528
    B.5.5Fax number+4940727 04295
    B.5.6E-mailsven.silberborth@almirall.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 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 nameLAS41007 (5% diclofenac gel)
    D.3.2Product code LAS41007 (5% diclofenac gel)
    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 INNDICLOFENAC SODIUM
    D.3.9.1CAS number 15307-79-6
    D.3.9.3Other descriptive nameDICLOFENAC SODIUM
    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) 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 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 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 INNDICLOFENAC SODIUM
    D.3.9.1CAS number 15307-79-6
    D.3.9.3Other descriptive nameDICLOFENAC SODIUM
    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) 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 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 keratosis. Patients to be considered have at least 6 but no more than 16 clinically confirmed AK target lesions of mild to moderate intensity in up to 3 treatment areas (TAs) with a size of 25 cm2 per TA (i.e. total size of TA is up to 75 cm2) and additionally one representative AK lesion for histological diagnosis of AK, which must be located in the face including the forehead (excluding eyelids, lips and mucosa) and/or bald scalp.
    E.1.1.1Medical condition in easily understood language
    Carcinoma in situ of the skin. Symptoms on skin: Rough, palpable, reddish. Occur on chronically sun-exposed skin, e.g. face, bald scalp, forearms.
    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 14.0
    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
    The primary objectives are to show:
    • superiority of LAS41007 compared to vehicle
    • superiority of LAS41007 compared to Solaraze®
    in the treatment of clinically confirmed grade I and II AK, each assessed by histology to evaluate the histological clearance of one pre-selected target lesion at 60 days post-treatment (PT, V6).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to show:
    • superiority of LAS41007 compared to vehicle
    • improved clinical efficacy of LAS41007 compared to Solaraze®
    in the treatment of clinically confirmed grade I and II AK with respect to clinical efficacy.

    Clinical efficacy will be assessed by:
    • AK lesion count (TLNS) to evaluate the complete clinical clearance (TLNS = 0) of all target lesions in the treatment area at 60 days PT (V6).
    • Additional clinical efficacy parameters, e.g. rate of clinical clearance and rate of responders, reduction of total AK target lesion area per patient, improvement of target lesions.

    Safety will be determined by incidence of adverse events, tolerability (overall and local), laboratory variables, vital signs and the patient's compliance.

    The objective of the non-interventional phase is to determine the maintenance of sustained complete clinical clearance, recurrences, and the incidence of squamous cell carcinoma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent,
    2. Caucasian male and female patients,
    3. Aged ≥ 18 years,
    4. Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception ,
    5. Have at least 6 but no more than 16 clinically confirmed AK target lesions of mild to moderate (grade I to II, according to Olsen et al, 1991) intensity in the whole treatment area (TA) (and additionally one representative AK lesion for histological diagnosis of AK), which must be located in the face including the forehead (excluding eyelids, lips and mucosa) and/or bald scalp,
    6. The AK target lesions must be discrete and quantifiable; the distance from one lesion to its neighbor lesion must be greater than 1.0 cm,
    7. The diameter of each AK target lesion should be not less than 0.5 cm and not greater than 1.5 cm,
    8. The target lesions must be located in up to 3 TAs with a size of 25 cm2 per TA (i.e. total area of TA is up to 75 cm2),
    9. Patient consents to take punch biopsies in the TA.
    Additionally, to be eligible for randomization, a patient must comply with the following criterion:
    10. Diagnosis of AK histologically confirmed by result of punch biopsy taken at screening visit (classification according to Röwert-Huber, 2007).
    E.4Principal exclusion criteria
    1. Have known hypersensitivity, intolerance or allergies against diclofenac sodium or other ingredients of the IMPs (hyaluronic acid, benzyl alcohol, poly ethyleneglycol monomethyl ether) and other non-steroidal anti-inflammatory agents,
    2. Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
    3. Have a history of gastrointestinal bleeding or perforation associated with prior therapy with NSAIDs,
    4. Have evidence of clinically significant or unstable medical conditions such as:
    - metastatic tumor or tumor with high probability of metastatic spread,
    - heart failure (NYHA class III or higher),
    - immunosuppressive disorder (e.g. HIV, patients following organ transplantation)
    - hematologic, hepatic, renal, neurologic or endocrine disorder,
    - collagen-vascular disorder (e.g. cerebro-vascular disorder or other bleedings),
    - gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage),
    5. Have currently and within the past 3 months other malignant tumors of the skin in the treatment areas (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma),
    8. Are known to be pregnant or lactating (currently or within the past 3 months),
    10. Have received the following topical treatments for any indication in the target area (defined as the whole face, including the forehead and the bald scalp) within 6 weeks before treatment with IMP: topical retinoids, topical steroids, topical 5-fluorouracil preparations, topical immunomodulators, topical diclofenac,
    11. Have received the following physical treatments in the TAs within the designated period before treatment with IMP: treatment (6 weeks), surgical excision - except biopsy for diagnostic confirmation (6 weeks), cryo-, thermo- or chemodestruction (6 weeks), photodynamic therapy (6 weeks), curettage (4 weeks),
    16. Anticoagulative therapy, e.g. with cumarines (e.g. phenprocoumon - e.g. trade name Marcumar® - or heparines throughout the interventional phase of 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,
    17. Patients having any significant physical abnormalities (e.g. tattoos, dermatoses) in the potential treatment areas that may cause difficulty with examination or final evaluation
    E.5 End points
    E.5.1Primary end point(s)
    The histological clearance of the (second) pre-selected target lesion at 60 days PT (V6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 days post treatment
    E.5.2Secondary end point(s)
    1. complete clinical clearance (target lesions); 2. responder rate (target lesions); 3. responder rate (cumulative lesions); 4. rate of clearance; 5. reduction of target lesion area per patient; 6. reduction of overall target lesion area; 6. AK severity scoring; 7. Inv. Global Improv. Index; 8. Patient Global Improv. Index; 9. Dermatol. Qual. of Life Quest.
    E.5.2.1Timepoint(s) of evaluation of this end point
    nos. 1-3, 6: 60 days post treatment; nos. 4-6: from baseline to each study visit; no. 7: at each visit after baseline; no. 8: at End of Treatment visit & 60 days post treatment; 9. at baseline & 60 days post 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Interventional phase:
    The interventional phase of the study will end with visit V6 of the last patient undergoing the trial.

    Non-interventional phase:
    The interventional phase will be followed by a non-interventional phase comprising two visits, scheduled 6 (FU M6) and 12 months (FU M12) after EoT (V5). Thus, the overall end of the study will be the visit FU M12 of the last patient.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 107
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 717
    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 824
    F.4.2.2In the whole clinical trial 824
    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)
    not applicable (not different from the expected normal treatment of that condition)
    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 Decision2010-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-07-16
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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