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    Summary
    EudraCT Number:2004-001949-15
    Sponsor's Protocol Code Number:AK 02
    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:2004-12-07
    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 number2004-001949-15
    A.3Full title of the trial
    PD P 506 A applied for 0.5, 1, 2 or 4 hours in combination with red light for photodynamic therapy of mild to moderate actinic keratosis
    A.4.1Sponsor's protocol code numberAK 02
    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 Sponsorphotonamic GmbH & Co. KG
    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 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.3.2Product code PD P 506 A
    D.3.4Pharmaceutical form Medicated plaster
    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.3.9.3Other descriptive namedelta-Aminolevulinic acid hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000
    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 typechemically defined
    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
    Determination of the optimal application duration (0.5, 1, 2 or 4 h) of PD P 506 A at fixed light dosage (37 J/cm²) and wavelength (630 +/- 3 nm) for the photodynamic therapy of mild to moderate actinic keratoses located on the head (hairless areas) including face.
    E.2.2Secondary objectives of the trial
    - Assessment of the safety of photodynamic therapy of actinic keratosis with PD P 506 A (PD P 506 A-PDT ).
    - Assessment of the safety of PD P 506 A application.
    - Assessment of the efficacy of PD P 506 A-PDT on a lesion basis at week 4 (visit 5).
    - Assessment of the efficacy of PD P 506 A-PDT on a patient basis at weeks 4 and 8 after therapy.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Written informed consent has been signed and dated
    - Caucasian male and female patients
    - Age > 18 years
    - Diagnosis of actinic keratosis (AK) which has been proven histologically in the
    patient’s history with at least three locally separated lesions located on the head
    (hairless areas) including the face
    -Selected AK study lesions are mild to moderate (grade I - II):
    Mild grade (I): Flat, pink maculae or patch on sun-damaged skin,
    background mottling, no roughness or hyper-keratosis.
    Moderate grade (II): Pink to red papule or plaque with rough, hyperkeratotic
    surface, variable induration.
    - The distance between the study lesion borders is > 1.0 cm
    - Maximum diameter of each study lesion is 1.8 cm
    - Skin sun sensitivity type I to IV according to Fitzpatrick
    E.4Principal exclusion criteria
    - PDT Non-responder
    - Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding the study (e.g. antineoplastic topical formulations as e.g. Metvix®, Solaraze®, 5-FU or vitamin A acid containing formulations)
    - Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding the study with keratolytic agents e.g. urea or salicylic acid containing formulations
    - Treatment with systemic retinoids during the 3 months preceding the study
    - Use of photosensitising drugs e.g. tetracycline within a time frame where photosensitisation from these drugs may still be present
    - Female patients of childbearing potential
    - Diagnosis of Porphyria
    - Known or suspect acute or chronic hepatic diseases (levels of ASAT, ALAT and/or gamma-GT more than 1.5 times the upper normal limit)
    - Manifest renal diseases with renal dysfunction
    - Known suppression of the immune system caused either virally or pharmacologically
    - Condition after organ transplantation
    - Any major concomitant disease
    - Psoriasis on the head
    - Skin diseases that might interfere with response evaluation of PD P 506 A-PDT
    - Skin sun sensitivity type V or VI according to Fitzpatrick
    - Known intolerance to one or more of the ingredients of the study medication
    - Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
    - Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
    - Suspected lack of compliance
    - Relationship of dependence between patient and sponsor or patient and investigator
    E.5 End points
    E.5.1Primary end point(s)
    Clinical complete clearance rate of treated actinic keratosis lesions at week 8 after therapy
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observer blinded
    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
    different application durations of the IMP
    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.8.5The 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 years0
    E.8.9.1In the Member State concerned months6
    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 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 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 state152
    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)
    Depending on the requirement and the discretion of the attending physician.
    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 Decision2005-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
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