Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-002510-12
    Sponsor's Protocol Code Number:ALA-AK-CT007
    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:2013-07-08
    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 number2013-002510-12
    A.3Full title of the trial
    A randomized, double-blind, phase III multi-center study to evaluate the safety and efficacy of BF-200 ALA (Ameluz®) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using BF-RhodoLED®
    Randomisierte, multizentrische, doppelblinde Phase-III-Studie zur Beurteilung der Sicherheit und Wirksamkeit von BF-200 ALA (Ameluz®) versus Placebo in der feldgerichteten Behandlung von leichter bis mäßiger Aktinischer Keratose mit photodynamischer Therapie (PDT) bei Verwendung der BF-RhodoLED® -Lampe
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the effective and safe use of the drug product Ameluz in the treatment of actinic keratosis (solar keratosis)
    A.4.1Sponsor's protocol code numberALA-AK-CT007
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiofrontera Bioscience 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 supportBiofrontera Bioscience GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiofrontera Bioscience GmbH
    B.5.2Functional name of contact pointClinical Trial Department
    B.5.3 Address:
    B.5.3.1Street AddressHemmelrather Weg 201
    B.5.3.2Town/ cityLeverkusen
    B.5.3.3Post code51377
    B.5.3.4CountryGermany
    B.5.4Telephone number+492148763226
    B.5.5Fax number+492148763290
    B.5.6E-mailameluz@biofrontera.com
    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 Ameluz®
    D.2.1.1.2Name of the Marketing Authorisation holderBiofrontera Bioscience GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 BF-200 ALA
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    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-Aminolaevulinic acid
    D.3.9.1CAS number 5451-09-2
    D.3.9.3Other descriptive nameAMINOLEVULINIC ACID HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21578
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number78
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboGel
    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
    Actinic keratosis (AK)
    E.1.1.1Medical condition in easily understood language
    Keratinization of the skin caused by intensive solar radiation.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the efficacy of BF-200 ALA with placebo, for the field-directed treatment of mild to moderate AK with PDT when using the BF RhodoLED® lamp.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and secondary efficacy parameters related to BF 200 ALA for field-directed treatment of AK with PDT when using the BF-RhodoLED® lamp.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Males or females between 18 and 85 years of age (inclusive)
    • Willing and able to sign the informed consent form. A study-specific informed consent must be obtained in writing for all patients before any study procedures
    • Presence of 4 to 8 clinically confirmed AK target lesions of mild to moderate intensity within 1-2 fields in the face or bald scalp (excluding eyes, nostrils, ears, and mouth), ie AK grade 1 and 2 according to Olsen et al 1991(1) (for description and grading of AK see Chapter 7.3.1 of the protocol).
    To document and confirm the diagnosis of the investigators:
    - A pre study biopsy must be taken from a representative AK lesion at the screening visit (Visit 1). The biopsy material will be histopathologically evaluated at a central laboratory by a dermatopathological expert according to the keratinocytic intraepithelial neoplasm (KIN) classification(3-5); (for description and grading of KIN see Chapter 7.3.1 of the protocol).
    The result of the biopsy will ultimately determine whether the patient is eligible for participation in this study. Patients may enroll only if the investigator´s clinical diagnosis of AK is confirmed by the histopathological evaluation.
    • Willingness to undergo a second biopsy of a representative lesion at the end of study visit (12 weeks after the last PDT) for evaluation
    • AK lesions must be discrete and measurable; the lesions have to be located within 1-2 fields of an overall size of approximately 20 cm2
    • The diameter of each AK lesion must be between 0.5 cm and 1.5 cm
    The size of each baseline AK lesion is determined by measuring the two largest perpendicular diameters. To describe irregular lesions (eg elipsoidal shape), investigators must measure the major and minor axes. The total area of the fields, where the lesions are located, must not exceed 20 cm2.
    • Free of significant physical abnormalities (eg tattoos, dermatoses) in the potential treatment region that may complicate examinations or final evaluations
    • Willingness to stop using moisturizers, ointments, creams, and any other topical treatments within the treatment region, including anti aging products, or products that contain vitamin A, vitamin D, and/or vitamin E- and green tea preparations, during the study. Sunscreens will be allowed, but they should not be applied to the treatment area within approximately 24 h before a clinical visit that involves lesion counts
    • Accept to abstain from extensive sunbathing and the use of a solarium during the period of the clinical visits. Patients experiencing sunburn within the treatment areas cannot be included until they have fully recovered
    • Good general health and/or stable health condition, as confirmed by a physical examination and medical history
    • Healthy patients or patients with clinically stable medical conditions, including but not limited to the following diseases, will be allowed to participate in the study if their medication is not prohibited by this protocol:
    - controlled hypertension
    - diabetes mellitus type II
    - hypercholesterolemia
    - osteoarthritis
    • Women of childbearing potential can participate in this study only if they have a negative serum pregnancy test at screening, and are willing to use a highly effective method of contraception. A female is considered to be of childbearing potential if she has a uterus and at least one ovary, has not had a tubal ligation, or is postmenopausal for less than 3 years. 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 properly used. This includes methods such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or sexual intercourse with a vasectomized partner. The use of condoms without spermicide coating is not considered to be a highly effective method of contraception.
    E.4Principal exclusion criteria
    • History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA
    • Current treatment with immunosuppressive therapy
    • Presence of porphyria
    • Hypersensitivity to porphyrins
    • Presence of photodermatoses
    • Presence of other malignant or benign tumors of the skin within the treatment area (eg malignant melanoma, BCC or SCC) within the last 4 weeks
    • Confirmed diagnosis of SCC for the representative lesion by screening biopsy
    • Presence of an inherited or acquired coagulation defect
    • Start of intake of medication with hypericin or systemically-acting drugs with phototoxic or photoallergic potential, such as psoralenes, tetracyclines, nalidixic acid, furosemide, amiodarone, phenothiacines, chinolones, fibrates, or phytotherapy with St. John’s wort, arnica, or valerian, or topically applied phototoxic substances like tar, pitch, psoralenes or some dyes like thiazide, methylene blue, toluidine blue, eosine, rose bengal, or acridine within 8 weeks prior to screening. Patients may, however, be enrolled if such medication was stopped 8 weeks prior to screening without evidence for an actual phototoxic/photoallergic reaction. Within 8 weeks prior to screening, such medication must not be newly prescribed. Should such a prescription become unavoidable for medical reasons during the clinical part of the trial, the investigator has to consult with the sponsor, who may discontinue the patient´s study participation, if deemed necessary. Clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or other major systemic diseases making the implementation of the protocol or interpretation of the study results difficult
    • Evidence of clinically significant (CS), unstable medical conditions such as:
    - metastatic tumor or tumor with high probability of metastasis
    - cardiovascular disease (New York Heart Association [NYHA] class III, IV)
    - immunosuppressive condition
    - hematologic, hepatic, renal, neurologic, or endocrine condition
    - collagen-vascular condition
    - gastrointestinal condition
    • Any topical treatment within the treatment area within 12 weeks prior to the first PDT session
    • Topical treatment with ALA outside the treatment area during participation in the study
    • Topical treatment with MAL during participation in the study
    • Topical treatment with immunomodulatory agents (eg imiquimod, ingenol mebutate) 4 weeks prior to the first PDT session
    None of the following systemic treatments within the designated period prior to the first PDT session:
    Interferon (6 weeks), Immunomodulators or immunosuppressive therapies (10 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 mcg/day for beclomethasone, or >600 mcg/day for fluticasone) (4 weeks), MAL or ALA (12 weeks)

    • Pregnancy
    • Breast feeding
    • Patients with any dermatological disease in the treatment area or surrounding region that may be exacerbated by treatment with topical 5-ALA, or that may cause difficulty with examinations (eg psoriasis, eczema)
    • Patients showing cornu cutaneum-like alterations of the skin in the face or on the bald scalp (ie target region)
    • Participation in a clinical study within 2 months prior to screening
    • Drug or alcohol abuse in the preceding 2 years
    • If the patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
    • If the patient is unlikely to comply with the protocol, eg uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
    • Confirmed diagnosis of human immunodeficiency virus (HIV)
    • Use of anti inflammatory painkillers (paracetamol will be permitted)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the overall patient complete response rate, ie the percentage of patients in which all treated lesions are completely cleared at the assessments performed 12 weeks after the last PDT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    See definition in sec. E.5.1
    E.5.2Secondary end point(s)
    1. Patient histopathological confirmed response rate
    2. Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-1
    3. Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT
    4. Patient partial response (complete clearance of at least 75% of the treated lesions) assessed 12 weeks after the last PDT
    5. Reduction of total lesion area (the size of all treated lesions added up) per patient 12 weeks after the last PDT
    6. Overall cosmetic outcome 12 weeks after the last PDT
    E.5.2.1Timepoint(s) of evaluation of this end point
    See definition in sec. E.5.2
    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 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    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 No
    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
    End of trial is defined as the planned date for last patient visit
    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 months9
    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.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state84
    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)
    After participation in the trial has ended, the patient will receive conventional treatment at the discretion of the investigator (e.g. cryotherapy, surgery or other).
    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 Decision2013-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-24
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 17:15:31 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA