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    Summary
    EudraCT Number:2007-003889-18
    Sponsor's Protocol Code Number:H 1005 6002-0702
    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:2008-03-10
    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 number2007-003889-18
    A.3Full title of the trial
    Study on the efficacy of Verrumal(R) compared to placebo and Solaraze(R) in the treatment of actinic keratosis grade I to II
    A.4.1Sponsor's protocol code numberH 1005 6002-0702
    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 Yes
    D.2.1.1.1Trade name Verrumal
    D.2.1.1.2Name of the Marketing Authorisation holderHermal Kurt Herrmann GmbH & Co OHG
    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 nameVerrumal
    D.3.4Pharmaceutical form Cutaneous solution
    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 INNFLUOROURACIL
    D.3.9.1CAS number 51218
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0. to 5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 69727
    D.3.9.3Other descriptive nameSALICYLIC ACID
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10. to 0
    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
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceutical Contracts Ltd.
    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
    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. to 0
    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 placeboCutaneous solution
    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
    Treatment of actinic keratosis grade I to II
    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
    Superiority to placebo and non-inferiority to Solaraze with respect to histological clearance of target lesion.
    E.2.2Secondary objectives of the trial
    - Superiority to Solaraze with respect to histological clearance of target lesion.
    - Improvement of treated lesions (lesion response).
    - Tolerability and safety by physicans global assessment score (PGA, PGT).
    - Tolerability and efficacy by patient's assessment and patient's compliance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent.
    2. Men and women aged between 18 and 85 years inclusive suffering from actinic keratosis grade I or II.
    3. Have a general good and stable health condition as confirmed by a physical examination and by medical history.
    4. Patients with clinically stable medical conditions including, but not limited to the following diseases will be allowed to be included into the study, if the medication taken for the treatment of the disease does not match the criteria of the excluded or disallowed medications listed in points 7, 8, 9, 10, 11, 12 and 13 of the exclusion criteria:
    - controlled hypertension
    - diabetes mellitus type II
    - hypercholesterolaemia
    - osteoarthritis
    5. Skin type I to IV according to Fitzpatrick.
    6. Accept to abstain from sunbathing and the solarium during the study.
    7. Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips and mucosa), i. e. actinic keratosis grade I and II according to Olsen EA et al. 1991.
    To document the diagnosis of the investigators, the AK-lesions will be photo-documented.
    8. The AK lesions must be discrete and quantifiable; the distance from one lesion to its neighbour lesion is greater than 1.0 cm.
    9. The diameter of each AK lesion is not less than 0.5 cm and not greater than 1.5 cm.
    Record the size of each baseline AK lesion by measuring the two largest perpendicular diameters. To describe irregular lesions (ellipsoidal) investigators will measure the major and minor axis. Both axes must be above the minimum of 0.5 cm and under the maximum of 1.5 cm.
    10. The whole area to be treated (test area) must not be greater than 25 scm. Quantity of lesions to be treated must be adapted accordingly.
    11. Are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
    12. Are willing to stop using moisturizers and any other topical treatments with anti-aging products, vitamin A, vitamin C, and/or vitamin E containing ointments and gels, and green tea preparations during the study within the treatment area. Sunscreens not containing vitamin E will be allowed, but should not be applied in the treatment area within approximately 24 hours before a clinical visit with lesion count.
    13. Physical ability to apply the study preparations correctly and to follow the study restrictions and visit.
    14. Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception. A female is considered to be of childbearing potential if she possesses an uterus and at least one ovary, has not had a tubal ligation, or she is not at least 3 years postmenopausal. Highly effective methods of birth control are defined as resulting in a low failure rate (Pearl Index below 1, failure rate less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. The use of condoms without spermicide coating is not considered to be a highly effective method of contraception.
    E.4Principal exclusion criteria
    1. Have received treatment of AK within the treatment area (face / scalp) in the three months preceding this clinical trial.
    2. Have known hypersensitivity to 5-fluorouracil, diclofenac sodium, salicylic acid, acetylsalicylic acid and other non-steroid antirheumatic agents.
    3. Are patients under immunosuppression therapy.
    4. Have inherited or acquired coagulation defects.
    5. Have evidence of clinically significant, unstable medical conditions such as
    • metastatic tumor or tumor with high probability of metastatic spread
    • cardiovascular (NYHA class III, IV)
    • immunosuppressive
    • hematologic, hepatic, renal, neurologic, endocrine
    • collagen-vascular
    • gastrointestinal
    6. Have currently other malignant or benign tumors of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, squamous cell carcinoma).
    7. Suffer from paresthesia.
    8. Have received the following treatments for any indication except for AK in the treatment area within the designated time period before treatment with study drug:
    Topical retinoids (6 weeks), Topical steroids (4 weeks), Topical diclofenac reparations (6 weeks), Topical 5-fluorouracil preparations (6 weeks), Topical immunomodulators (6 weeks), Surgical excision (except biopsy for diagnostic confirmation; 6 weeks), Curettage (4 weeks), Cryo-, thermo- or chemodestruction (6 weeks), Photodynamic therapy (6 weeks), Therapeutic UV-Radiation (6 weeks).
    9. Have received the following systemic treatments within the designated period before treatment with study drug:
    Interferon (6 weeks), Immunomodulators or immuno-suppressive therapies (12 weeks), Cytotoxic drugs (6 months), Investigational drugs (8 weeks), Drugs known to have major organ toxicity (8 weeks) Corticosteroids (oral or injectable; 6 weeks), Inhaled corticosteroids (>1200 µg/day for beclomethasone,
    or >600 µg/day for fluticasone; 4 weeks).
    10. Patients taking phenytoin, methotrexate or sulfonylurea.
    11. Patients taking inhibitors of DPD (e.g. Brivudin, Sorivudin)
    12. Known allergy against dimethylsulfoxide, ethanol, ethyl acetate, pyroxyline, poly(butyl)methacrylate, methylmethacrylate, sodium hyaluronate, benzyl alcohol, poly ethyleneglycol monomethyl ether.
    13. Known DPD deficiency.
    14. Are known to be pregnant or lactating (currently or within the past 3 months).
    15. Have any dermatological disease in the treatment area or surrounding area that may be exacerbated by treatment with topical Verrumal® or Solaraze® gel or cause difficulty with examination (e.g. psoriasis, eczema, dermatitis exfoliativa).
    16. Show Cornu cutaneum like alterations of the skin in the face or on the bald scalp (target area).
    17. Are currently or within the past 8 weeks participating in another clinical study.
    18. Have active chemical dependency or alcoholism as assessed by the investigator.
    19. Patient is institutionalized because of legal or regulatory order.
    E.5 End points
    E.5.1Primary end point(s)
    histological status of target lesion (cleared, not cleared) 8 weeks post treatment end
    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 Yes
    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.8.3 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 concerned40
    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
    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 months
    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 state470
    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 Decision2008-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-07
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