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    Summary
    EudraCT Number:2011-003317-41
    Sponsor's Protocol Code Number:11-02/Diclo-G
    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:2011-09-01
    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 number2011-003317-41
    A.3Full title of the trial
    Double-blind, randomized, clinical trial to compare the efficacy and safety of diclofenc 3% gel vs. Solaraze 3% gel vs. vehicle for the treatment of patients with actinic keratosis.
    Doppelblinde, randomisierte, klinische Studie zum Nachweis der Wirksamkeit und Verträglichkeit von Diclofenac 3% Gel vs. Solaraze 3% Gel vs. Grundlage bei Patienten mit aktinischer Keratose.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vergleich eines bekannten Arzneimittels zur Behandlung der aktinischen Keratose (eine durch langzeitige Sonneneinwirkung hervorgerufene Hauterkrankung) mit einem neuen Arzneimittel (mit gleichem Wirkstoff) und der Grundlage ohne Wirkstoff.
    A.3.2Name or abbreviated title of the trial where available
    Diclo Gel
    A.4.1Sponsor's protocol code number11-02/Diclo-G
    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 SponsorDermapharm AG
    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 supportDermapharm AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDermapharm AG
    B.5.2Functional name of contact pointHead of Clinical Department
    B.5.3 Address:
    B.5.3.1Street AddressLil-Dagover-Ring 7
    B.5.3.2Town/ cityGruenwald
    B.5.3.3Post code82031
    B.5.3.4CountryGermany
    B.5.4Telephone number004908964186121
    B.5.5Fax number004908964186110
    B.5.6E-mailgabriele.bast@dermapharm.de
    D. IMP Identification
    D.IMP: 1
    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 holderAlmirall 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 IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiclofenac
    D.3.9.1CAS number 15307-79-6
    D.3.9.3Other descriptive nameDICLOFENAC SODIUM
    D.3.9.4EV Substance CodeSUB01674MIG
    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.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 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 nameDiclofenac 3% Gel
    D.3.4Pharmaceutical form Gel
    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 INNDiclofenac
    D.3.9.1CAS number 15307-79-6
    D.3.9.3Other descriptive nameDICLOFENAC SODIUM
    D.3.9.4EV Substance CodeSUB01674MIG
    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 placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    actinic keratosis
    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
    Evaluation of the efficacy and safety of a new diclofenac 3% gel formulation vs. the originator Solaraze (licensed) vs. vehicle in patients with actinic keratosis
    E.2.2Secondary objectives of the trial
    The following parameters are defined as secondary in the study protocol:
    Course of the cumulative lesion number score (CLNS) between beginning of treatment (day 0) and final examination or early termination.
    Evaluation of the global improvement by the investigator (IGII) and by the patient (PGII) during the whole study course.
    Proportion of patients with the IGII rating "cured" at final examination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) immunocompetent men or women, 18 years or older
    2) written consent form
    3) diagnosis: actinic keratosis
    4) at least five (5) and no more than ten (10) clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions, each at least 4 mm in diameter, contained within a 25-cm² treatment area located on the face or bald scalp
    5) women of child bearing potential: use of a highly effective method of contraception during the whole course of the study
    6) women: negative pregnancy test prior to study start
    E.4Principal exclusion criteria
    1) presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, sunburn or other possible confounding skin conditions in or near the treatment area
    2) use within six months prior to randomization of oral retinoids
    3) use within one month prior to randomization of immunomodulators or immunosuppressive therapies, interferon, oral corticosteroids or cytotoxic drugs
    4) use within six months prior to randomization on the face or bald scalp of chemical peel, dermabrasion, laser abrasion, PUVA therapy, or UVB therapy
    5) use within one month prior to randomization on the face or bald scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, or other treatment for actinic keratosis
    6) known allergy or hypersensitivity to diclofenac or other excipients in one of the test products
    7) known hypersensitivity reactions like asthma, rhinitis or urticaria to acetyl salicylic acid or other NSAIDs in the past
    8) active gastrointestinal ulceration or bleeding
    9) severe renal or hepatic impairment
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the proportion of patients in the per protocol population with treatment success (100% clearance of all AK lesions within the treatment area) at the final examination (30 days after completion of 90 days of treatment).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Start of therapy (day 0) and end of study (day 120, visit 5).
    E.5.2Secondary end point(s)
    1) Course of the cumulative lesion number score (CLNS) between beginning of treatment (day 0) and final examination or early termination.
    2) Evaluation of the global improvement by the investigator (IGII) and by the patient (PGII) during the whole study course.
    3) Proportion of patients with the IGII rating "cured" at final examination.
    4) Evaluation of the tolerability of the treatment by the investigator and the patient
    5) safety laboratory
    6) assessment of adverse events in the course of the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at every visit
    2), 4), 6) every visit from visit 2 on
    3) last visit (visit 5)
    5) begin (visit 1) and end of therapy (visit 4)
    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) 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 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
    last visit of last subject
    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 months0
    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 months0
    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: 330
    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 No
    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 state330
    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 Decision2011-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-22
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