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    Summary
    EudraCT Number:2005-003617-33
    Sponsor's Protocol Code Number:03-2005
    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:2006-05-22
    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 number2005-003617-33
    A.3Full title of the trial
    A Randomised Cross-Over Study to Explore the Pathophysiological Mechanisms Involved in the Treatment of Actinic Keratoses with Solaraze
    A.3.2Name or abbreviated title of the trial where available
    Solaraze Mode of Action Study
    A.4.1Sponsor's protocol code number03-2005
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorCharité
    B.1.3.4CountryGermany
    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 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 Information not present in EudraCT
    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
    D.3.2Product code 42752.00.00
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameDiclofenac-Natrium
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typenot less then
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticarcinogenic drug and antiinflammatory drug
    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 keratosis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the modulation of key factors involved in the pathophysiology of Actinic Keratosis by Solaraze.
    Comparison of levels of expression of the chosen factors between active treatment and no treatment.
    E.2.2Secondary objectives of the trial
    Efficacy will be measured by comparing target lesion number score (TLNS) and cumulative lesion number score (CLNS) at baseline to the end of study timepoint.
    Safety will be monitored throughout the study.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Are willing and able to give written informed consent.
    2. Are at least 18 years of age.
    3. Have a minimum of 3 typical, visible and histologically proven Actinic Keratoses in the observation area (50 cm2) on one of the following regions: forehead, central face, scalp.
    4. Patient is suffering from Actinic Keratoses with a minimum duration of 3 months
    5. Are willing to eliminate tanning bed/sun parlor use during the study.
    6. Are willing to stop using moisturizers and over-the-counter retinol products or products containing alpha or beta hydroxyacids in the observation area during the study.
    7. Are willing and able to participate in the study as an outpatient, make frequent visits to the clinic, and comply with all study requirements, including the following:
     3 clinic visits
     application of Solaraze® gel on observation area
     pretreatment biopsy for histological confirmation of AK-diagnosis and skin biopsy from univolved skin for laboratory (pathophysiological mechanisms)
     posttreatment biopsy for histological confirmation of AK-clearance or -persistence
     urine pregnancy testing for females of childbearing potential at treatment initiation
    7. If female and of childbearing potential, subject is using a suitable form of contraception.
    E.4Principal exclusion criteria
    1. Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease. Note: Patients with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolaemia, or osteoarthritis will be allowed to enter the study. Have asthma or active gastrointestinal ulceration/bleeding.
    2. Have any dermatological disease and or condition in the observation area or in the surrounding area (3cm distance from observation area) that may be exacerbated by treatment with Solaraze® gel or cause difficulty with examination (eg, rosacea, psoriasis, atopic dermatitis, eczema).
    3. Are currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 4 weeks.
    4. Have active chemical dependency or alcoholism, as assessed by the investigator.
    5. Have known allergies to any of the ingredients of the study drug, i.e. allergy or hypersensitivity to aspirin or other NSAID
    6. Pregnancy or lactating.
    7. Have received any treatment at the observation area within a time period of 2 months.
    8. Have invasive tumors within the observation area (eg., squamous cell carcinoma).
    Note: A biopsy of any lesion within the observation area suggestive of malignancy should be performed. If squamous cell carcinoma or other malignant conditions are confirmed within the observation area, the patient will not be included in the study.
    9. Have received any cancer chemotherapy, or radiation therapy, within 6 months prior to study treatment initiation (patient must not have any evidence of systemic cancer).
    10. Have received topically applied steroids within 4 weeks prior to treatment.
    11. Have received the following systemic treatments within the designated period before study treatment initiation:
    Treatment Time Period
    Interferon 4 weeks
    Corticosteroids (oral or injectable) 4 weeks
    Inhaled corticosteroids (>1200 g/day for beclomethasone
    Or >600 g/day for fluticasone) 4 weeks
    Retinoids 4 weeks
    Investigational drugs 4 weeks
    Drugs known to have major organ toxicity 4 weeks
    Immunomodulators or immunosuppressive therapies 4 weeks
    12. Have received 15000 units per day of Vitamine A or derivates within 2 weeks prior to study treatment initiation.
    13. Have used any topical preparations, such as over-the-counter retinol products, moisturizers, sunscreens or body oils, or alpha or beta hydroxyacids in the observation area within 24 hours prior to the visit.
    14. Have used sunscreen in the observation area within a minimum of approximately 24 hours prior to study treatment initiation.
    15. Have received Non steroidal anti-immflamatory drugs within 4 weeks prior to treatment.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of the modulation of key factors involved in the pathophysiology of Actinic Keratosis by Solaraze.
    Comparison of levels of expression of the chosen factors between active treatment and no 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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Mode of action
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    each subject serves as its own control
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Start: September 2005
    End of recruitment: October 2005
    Treatment period: 90 days

    First patient in: September 2005
    Last patient out: July 2006

    In the complete trial will be 20 subjects included. Every subject will be take part of the study for 240 days, with 90 days treatment period.
    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 months10
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2005-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-12-31
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