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    Summary
    EudraCT Number:2008-000459-88
    Sponsor's Protocol Code Number:PDT08
    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:2008-10-14
    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 number2008-000459-88
    A.3Full title of the trial
    Prospective, randomized study of the efficacy of photodynamic therapy in actinic keratosis
    A.3.2Name or abbreviated title of the trial where available
    PDT in AK
    A.4.1Sponsor's protocol code numberPDT08
    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 SponsorUniv.-Prof. Dr. Hans F. Merk, Dept. of Dermatology, University Hospital, RWTH Aachen University
    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 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 name5-Aminolevulinic acid hydrochloride (ALA)
    D.3.2Product code BF-200 ALA
    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 INN5-Aminolevulinic acid hydrochloride
    D.3.9.1CAS number 5451-09-2
    D.3.9.2Current sponsor codeALA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    We treat patients with superficial actinic keratosis grade I-II on the face or scalp.
    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
    Our preliminary experience with the Hydrosun-radiator (halogen lamp) indicates that photodynamic therapy (PDT) with visible light (VIS) and water-filtered infrared A (wIRA) compared to conventional light sources such as Aktilite 128 (light-emitting diode, LED) is significantly less painful. We therefore want to investigate on the one hand the influence of wIRA on pain sensations during PDT and to document the treatment success. On the other hand, we want to investigate the influence of wIRA on the penetration depth and thereby on therapeutic outcome.
    The questions are therefore:
    I. Is there less pain during VIS/wIRA-PDT compared to VIS-PDT?
    II Is the therapeutic effect of the VIS/wIRA-PDT worse, comparable to or better than those of the VIS-PDT?
    III. Can the therapeutic efficacy of PDT be improved by promoting the penetration of the photosensitizer?
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who comply with the following criteria will be selected for the study:
    - Willing and able to sign informed consent form.
    - Men aged between 45 to 85 years.
    - Postmenopausal women (at least 3 years postmenopausal, 45 to 85 years)
    - Histologically or clinically confirmed diagnosis of actinic keratosis grade I (mild actinic keratosis: better palpable [skin roughness], than visible) and grade II (moderate actinic keratosis: palpable [roughness] and visible [red macula or papule with mild keratosis]) of the face and scalp. A histopathologic assessment will be performed in case of doubt to exclude basal cell carcinoma, squamous cell carcinoma, actinic porokeratosis or lentigo-maligna.
    - Have a good and stable health condition on the basis of the entrance examination and patient history.
    E.4Principal exclusion criteria
    Patients may not participate if they meet any of the following criteria:
    - Women and men under the age of 45 years.
    - Premenopausal, pregnant or breastfeeding women (currently or within the past 3 months)
    - History of or clinically proven photodermatoses, porphyria, hypersensitivity to porphyrins or generally known photosensitivity.
    - Use of topical medications such as topical steroids, retinoids, imiquimod or 5-fluorouracil within 3 months before the start of the study.
    - Immunosuppressive medication (corticosteroids, methotrexate, cyclosporine, azathioprine, chemotherapy, immunotherapy ect.) within 3 months before the start of the study.
    - Laser resurfacing or chemical peelings of the areas to be treated within 2 months before inclusion in the study.
    -Treatment with photosenzitising drugs like psoralenes, tetracyclines, nalidixic acid, furosemide, amiodarone, phenothiacines, chinolons, fibrates, phytotherapy with St. John`s wart, arnica, valerian or topically applied phototoxic substances like tar, psoralenes or some dyes like thiazide, methylene blue, toluidine blue, eosine, Bengal red, or acridine.
    - Known allergies, hypersensitivity reactions or intolerance to the drug and the ingredients of the 10% BF-200 ALA-gel: soy lecithine, polysorbate 80, caprylic/capric acid triglycerides, isopropyl alcohol, disodium phosphate dihydrate, sodium hydroxide, propylene glycole, sodium benzoate.
    - Simultaneous participation in other studies.
    - Other causes, which lead occording to the investigator to an exclusion from the study.
    - Servere systemic disease (egg. cardiovascular (NYHA class III, IV), hematologic, hepatic, renal, endocrine, metastatic tumour disease)
    - Lately diagnosed premalignant or malignant skin disease in the treatment area (hypertrophic, hyperkeratotic actinic keratosis grade III, Cornu cutaneum-like lesions, malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
    - Severe local reaction (massive erythema with pronounced edema, erosions and pustular reaction), a second PDT will not be performed.
    E.5 End points
    E.5.1Primary end point(s)
    After six months the final examination of each patient is performed.
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparision of different treatment modalities.
    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 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
    All data are provided in the protocol. The trail is finalized after the last visit 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 months0
    E.8.9.1In the Member State concerned 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.1.3Elderly (>=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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    We recommend yearly controls of the skin by dermatologists.
    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 Decision2008-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-16
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