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    Summary
    EudraCT Number:2013-003241-42
    Sponsor's Protocol Code Number:ALA-BCC-CT008
    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:2013-11-08
    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 number2013-003241-42
    A.3Full title of the trial
    A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of BF-200 ALA (Ameluz®) in comparison to Metvix® in the treatment of non-aggressive basal cell carcinoma (BCC) with photodynamic therapy (PDT)
    Eine randomisierte, Beobachter-verblindete, multinationale Phase III Studie zur Beurteilung der Verträglichkeit und Wirksamkeit von BF-200 ALA (Ameluz®) gegenüber Metvix® bei der Behandlung von nicht-aggressivem Basalzellkarzinom (BCC) mit photodynamischer Therapie (PDT)
    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 in the treatment of basal cell carcinoma
    A.4.1Sponsor's protocol code numberALA-BCC-CT008
    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+492148763241
    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(R)
    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.3.4Pharmaceutical 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.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 Metvix(R)
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma Laboratorium GmbH
    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.3.4Pharmaceutical form Cream
    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 INNmethyl aminolevulinate
    D.3.9.1CAS number 79416-27-6
    D.3.9.3Other descriptive nameMETHYL AMINOLEVULINATE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21579
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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.IMP: 3
    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(R)
    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.3.4Pharmaceutical 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Basal cell carcinoma (BCC)
    E.1.1.1Medical condition in easily understood language
    Rodent ulcer - small, fair papules, flesh-colored, round or oval translucent nodule, or scaly, localized plaque in frequently sun-exposed skin
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10004146
    E.1.2Term Basal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 containing 7.8% 5-aminolevulinic acid (ALA) as active ingredient with the comparator Metvix®, containing 16% methyl-aminolevulinate in the treatment of thin, non-aggressive BCC with photodynamic therapy.
    E.2.2Secondary objectives of the trial
    • Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT,
    • Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT,
    • Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2,
    • The overall cosmetic outcome 12 weeks after the last PDT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Willing and able to sign a study-specific ICF, which must be obtained in writing for all patients before any study procedures
    • Men or women ≥18 years of age (inclusive)
    • Presence of 1- 3 primary BCC lesions in face/forehead outside H-zone , bald scalp, extremities and/or neck/trunk, all of which are, according to clinical judgment of investigator, likely to fulfil criteria for positive outcome of histological assessment (non-aggressive BCCs comprising primary superficial, nodular, or mixed superficial/nodular BCC with a thickness ≤2 mm). Only eligible lesions with confirmation by biopsy taken at screening are allowed to be included in the study, lesions assessed as non-eligible should be excised by surgery or removed by cryotherapy in a timely manner. Other treatments are not allowed for these lesions.
    To document and confirm investigator’s clinical diagnosis of non-aggressive behavior and thickness of the lesions, pre-study biopsies must be taken at the screening visit from all BCC lesions . 3-mm biopsies should be taken at the region of the tumor which, according to clinical judgment, appears thickest.
    Biopsy material will be histopathologically evaluated by a dermatopathological expert according to WHO classification/subtyping. Ifno clear histopathological assessment can be performed second biopsy may be taken after approval of sponsor. Hence, time interval between Visit 1 / Visit 2 has to be expanded accordingly
    The result of biopsies will ultimately determine whether the patient is eligible for the study; patient may only be enrolled if the investigator’s clinical diagnosis of non-aggressive BCC with a thickness of ely determine whether the patient ie lesion by the histopathological evaluation according to WHO classification guideline
    • The diameter of each lesion should range between ≥0.5 cm and ≤2 cm;total maximal treated area must not be larger than approximately 10 cm² (including a 0.5 – 1.0 cm margin surrounding each lesion).Size of each baseline BCC lesion is determined by measuring the two largest perpendicular diameters.To describe irregular lesions (ellipsoidal) the major and minor axes must be measured,which must both be within the acceptable limits defined above
    • Target BCC lesions must be discrete and quantifiable and have to be located within 1 to 2 treatment areas. Target lesions must be placed within max. 2 illumination areas (illumination area is defined by the effective illumination area of the BF-RhodoLED® device with approx. 6 x 16 cm)
    • Patients displaying non-eligible lesions by biopsy taken at screening should be included in the study if at least one lesion is eligible and non-eligible lesions are at least 10 cm apart from eligible lesion(s). The non-eligible lesions should timely be removed by surgery or cryotherapy.
    • Willingness to undergo biopsy at the end of the observer blind part of the study 12 weeks after last PDT in case of partial or non-responding lesions
    • Willingness to receive up to 4 PDTs within 3.5 months
    • Free of significant physical abnormalities in the potential treatment area that may cause difficulty with examination or final evaluation
    • Willingness to stop use of moisturizers and any other topical treatments within the treatment area (during observer blind part), incl. anti-aging products, vitamin A-, vitamin D-, and/or vitamin E-containing ointments /creams, and green tea preparations during the study. Sunscreens will be allowed, but should not be applied in the treatment area within approx. 24 h before a clinical visit involving lesion count
    • Accept to abstain from extensive sunbathing and use of a solarium during the observer blind part of the study. Patients with sunburn within the treatment areas cannot be included until fully recovered
    • Healthy patients or patients with clinically stable medical conditions as confirmed by physical examination and by medical history, including but not limited to controlled hypertension, diabetes mellitus type II, hypercholesterolemia, and osteoarthritis, will be permitted to be included in the study if their medication is not prohibited by this protocol
    • Women of childbearing potential are permitted to participate in this study only if they have a negative serum pregnancy test at screening and a willingness to use a highly effective method of contraception during observer blind part of the study. A woman is considered to be of childbearing potential if she possesses a uterus and at least one ovary, has not had a tubal ligation, or is not postmenopausal for at least 3 years. Highly effective methods of birth control are defined as resulting in a low failure rate (Pearl Index below 1) when properly used. This includes methods such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or sexual intercourse with a vasectomized partner. 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
    • History of hypersensitivity to MAL or any ingredient of Metvix® cream including arachis oil,or to peanut or soya
    • Current treatment with immunosuppression therapy
    • Presence of porphyria
    • Hypersensitivity to porphyrins
    • Presence of BCC lesions on embryonic fusion planes (H-zone)
    • Presence of more than 3 BCCs
    • Presence of malignant or benign tumors of skin other than non-aggressive BCC within treatment area (eg melanoma,SCC,aggressive BCC clearly diagnosed at screening visit by clinical assessment) within last 12 weeks
    Treatment areas are defined as whole face (without H-zone) + forehead, bald scalp , neck, dorsal and back (neck/trunk) + extremities
    • Gorlin Syndrome or Xeroderma pigmentosum
    • Presence of photodermatoses
    • Recurrent or pigmented BCCs or clearly clinically diagnosed aggressive BCCs incl. morpheiform BCC
    • Treatment of lesions (AK,BCC,SCC,Bowens disease,melanoma) ≤12 weeks prior to first PDT, except physical treatments that will not be allowed ≤6 weeks prior to first PDT. Lesion(s) that seemed eligible by clinical judgment but could not be confirmed to be eligible by biopsy at screening, and which are located at a distance of ≥10 cm to an eligible lesion should be excised surgically or removed by cryotherapy in a timely manner. Such lesions must not be treated by PDT or topical medicaments during the observer blind part
    • Presence of lesion(s) which are assessed as non-eligible by biopsy at screening less than 10 cm away from a suitable lesion
    • Presence of 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,valerian,or topically applied phototoxic substances ,within 8 weeks prior to screening. Patients may be enrolled if such medication was taken for more than 8 weeks prior to screening without evidence of a phototoxic/photoallergic reaction. Within 8 weeks prior to screening and during observer blind part, such medication must not be newly prescribed. Should such a prescription become unavoidable for medical reasons during clinical part of the trial, investigator has to consult with sponsor,who may discontinue the patient’s study participation,if deemed necessary
    • Clinically relevant cardiovascular,hepatic,renal,neurologic, endocrine, or other major systemic disease making implementation of protocol or interpretation of study results difficult
    • Evidence of clinically significant (CS), unstable medical conditions, such as:
    − Metastatic tumor or tumor with high probability of metastatic spread
    − Cardiovascular disease (New York Heart Association class III, IV)
    − Immunosuppressive condition
    − Hematologic,hepatic,renal,neurologic, or endocrine condition
    − Collagen-vascular condition
    − Gastrointestinal condition
    • Topical treatment with 5-ALA or MAL outside treatment area during observer blind part
    • Any topical treatment incl. diclofenac and immunomodulatory agents 12 weeks prior to first PDT session and during observer blind part
    • Any physical treatment during observer blind part within treated area(s) with the exception of lesion(s) that could not be confirmed to be eligible by biopsy at screening and which are located at a distance of ≥creening and which are locat
    • None of the following systemic treatments within designated period prior to first PDT and during observer blind part of study:
    - 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 µg/day for beclomethasone, or >600 µg/day for fluticasone) (4 weeks)
    - MAL or 5-ALA (12 weeks)
    • Pregnancy
    • Breast feeding
    • Patients with any dermatological disease in treatment region or surrounding region that may be exacerbated by treatment with topical 5-ALA or MAL or that may cause difficulty with examinations (eg psoriasis,eczema)
    • Patients showing cornu cutaneum-like alterations of the skin in face or on the bald scalp (ie treatment region)
    • Participation in a clinical study within 2 months prior to screening
    • Drug or alcohol abuse in the preceding 2 years
    • Patient is investigator,any subinvestigator,research assistant,pharmacist,study coordinator, other staff, or relative thereof directly involved in conduct of the protocol
    • Mental condition rendering the patient unable to understand nature,scope,and possible consequences of the study
    • Patient is unlikely to comply with protocol,eg uncooperative attitude, inability to return for FU visits,and unlikelihood of completing study
    • Confirmed diagnosis of human immunodeficiency virus (HIV)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the overall patient complete response assessed clinically 12 weeks after the last PDT. An overall complete responder is defined as a patient in whom all treated lesions were cleared 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)
    • Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT,
    • Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT,
    • Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2,
    • The 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 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 blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    The end of the study is defined as the date of the last FU visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial 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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state235
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 272
    F.4.2.2In the whole clinical trial 272
    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)
    All patients whose BCC lesions did not completely clear 12 weeks after the last PDT will receive a conventional treatment of their remaining BCC at the discretion of the investigator.
    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 Decision2013-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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