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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2006-000815-24
    Sponsor's Protocol Code Number:01-2006
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-05-16
    Trial 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 number2006-000815-24
    A.3Full title of the trial
    A randomized study of topical 3% Diclofenac in a 2.5% Hyaluronate base (Solaraze® 3% Gel) versus topical 5% 5-Fluorouracil (Efudix® Cream) versus liquid nitrogen spray cryotherapy in immunosufficient patients with actinic keratoses
    – a single center study
    A.3.2Name or abbreviated title of the trial where available
    H2H Solaraze-5FU-Cryo
    A.4.1Sponsor's protocol code number01-2006
    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® 3% Gel
    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 nameDicolfenac-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
    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 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 nameEfudix® Cream
    D.3.2Product code 6029133.00.00
    D.3.4Pharmaceutical form Cream
    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 INN5-Fluorouracil
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive name5-FU
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typenot less then
    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 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
    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
    Clinically efficacy: (a) percent reduction of lesions after end-of-treatment in relation to individual baseline lesions; (b) recurrence rates of lesions after end-of-treatment and in follow-up period; (c) occurrence of new lesions after end-of-treatment and in follow-up period
    E.2.2Secondary objectives of the trial
    1. Assessment of oncogene staining before and after treatment
    2. Safety assessment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients may participate in the study if they:
    1. Are willing and able to give written informed consent.
    2. Are at least 18 years of age.
    3. Have a minimum of 5 Actinic Keratoses in the treatment area (50 cm2) on forehead, central face or scalp.
    4. The Actinic Keratoses must be suitable for treatment with Solaraze, Efudix and Cryotherapy.
    5. The Actinic Keratoses will be graded from low to moderate (°I and °II)
    6. Patient is suffering from Actinic Keratoses with a minimum duration of 3 months
    7. Are willing to eliminate tanning bed/sun parlor use during the study.
    8. Are willing to stop using moisturizers and over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment area during the study.
    9. 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:
    · 7 clinic visits during (screening, treatment, post-treatment, and follow-up period)
    · application of cream respectively ointment on treatment area
    · pretreatment biopsy for histological confirmation of AK-diagnosis and skin biopsy from univolved skin for laboratory (tumor markers)
    · 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 highly effective form of contraception. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used cinsistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they:
    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.
    2. No patient with Actinic Keratoses with grading severe (°III) in the treatment area is allowed to participate in the study
    3. Have any dermatological disease and or condition in the treatment that may be exacerbated by treatment with Solaraze, Efudix, Cryotherapy or cause difficulty with examination (eg, rosacea, psoriasis, atopic dermatitis, eczema).
    4. Are currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 4 weeks.
    5. Have active chemical dependency or alcoholism, as assessed by the investigator.
    6. Have known allergies to any of the ingredients of the study drugs, i.e. allergy or hypersensitivity to acetylsalicylic acid or other NSAID
    7. Pregnancy or lactating.
    8. Have received any treatment at the treatment area within a time period of 2 months.
    9. Have invasive tumors within the treatment area (eg., squamous cell carcinoma).
    Note: A biopsy of any lesion within the treatment area suggestive of malignancy should be performed at the prestudy screening visit. If squamous cell carcinoma or other malignant conditions are confirmed within the treatment area, the patient will not be included in the study.
    10. 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).
    11. Have received topically applied steroids within 4 weeks prior to treatment.
    12. Have received the following systemic treatments within 4 weeks before study treatment initiation: Interferon, Corticosteroids (oral or injectable), Inhaled corticosteroids (>1200 mg/day for beclomethasone or >600 mg/day for fluticasone), retinoids, investigational drug, drugs known to have major organ toxicity, immunomodulators or immunosuppressive therapies, NSAIDs
    13. Have received >15000 units per day of Vitamine A or derivates within 2 weeks prior to study treatment initiation.
    14. Have used any topical preparations, such as over-the-counter retinol products, moisturizers, sunscreens or body oils, or alpha or beta hydroxyacids in the treatment area within 24 hours prior to the all visit.
    15. Have used sunscreen in the treatment area within a minimum of approximately 24 hours prior to study treatment initiation.
    E.5 End points
    E.5.1Primary end point(s)
    Clinically efficacy: (a) percent reduction of lesions after end-of-treatment in relation to individual baseline lesions; (b) recurrence rates of lesions after end-of-treatment and in follow-up period; (c) occurrence of new lesions after end-of-treatment and in follow-up period
    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
    Oncogene Analysis
    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 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 Yes
    E.8.2.3.1Comparator description
    Spray-Cryotherapy with liquid nitrogen
    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: 1st of July 2006 (inclusion of last pt. 6 month after start)
    Inclusion period: 1st of July 2006 – 31st of December 2006
    Treatment period: max. 3 months
    End of Phase I (treatment period): 30th of April 2007
    End of Phase II (folllow up period): 30th of April 2008
    Final report: June 2008
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 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 2006-05-16. 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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 75
    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 Decision2006-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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