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    Summary
    EudraCT Number:2015-004111-20
    Sponsor's Protocol Code Number:Q291dnro62/2015
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-29
    Trial 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 ConcernedFinland - Fimea
    A.2EudraCT number2015-004111-20
    A.3Full title of the trial
    Photodynamic therapy for Lentigo maligna with 5-aminolaevulinic acid nanoemulsion (BF-200 ALA)
    Lentigo malignan fotodynaaminen hoito käyttäen valoherkistäjänä BF-200 ALA:a
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Photodynamic therapy for melanoma precursor lesion Lentigo maligna using 5-aminolevulinic acid nanoemulsion as a light sensitizing cream
    Melanooman esiastemuutoksen Lentigo malignan valoaktivaatiohoito käyttäen valoherkistäjänä 5-aminolevulinaatti-nanoemulsiota
    A.4.1Sponsor's protocol code numberQ291dnro62/2015
    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 SponsorJanne Räsänen
    B.1.3.4CountryFinland
    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 supporttutkijalähtöinen tutkimus
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanne Räsänen
    B.5.2Functional name of contact pointJanne Räsänen
    B.5.3 Address:
    B.5.3.1Street AddressIlmarinkatu 32 C 118
    B.5.3.2Town/ cityTampere
    B.5.3.3Post code33500
    B.5.3.4CountryFinland
    B.5.4Telephone number+358503777145
    B.5.6E-mailjaerasan@student.uef.fi
    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 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 Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    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
    Lentigo maligna
    Lentigo maligna
    E.1.1.1Medical condition in easily understood language
    Precursor lesion of malignant melanoma
    Malignin melanooman esiastemuutos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To investigate the efficacy of photodynamic therapy for treating Lentigo maligna using 5-aminolevulinic acid nanoemulsion as a light sensitizing cream. Patients receive photodynamic treatment three times consecutively with intervals of two weeks. Four weeks after last photodynamic treatment the Lentigo maligna will be removed surgically from the skin. Result of the treatment is assessed with histopatological examination and immunohistochemical staining of removed tissue specimen.
    Selvittää, onko fotodynaaminen hoito tehokas Lentigo malignan hoitomuoto käyttäen valoherkistäjän 5-aminolevulinaatti-nanoemulsiota. Potilaat saavat fotodynaamista hoitoa yhteensä kolme kertaa kahden viikon välein. Neljän viikon kuluttua viimeisestä fotodynaamisesta hoidosta Lentigo maligna leikataan iholta kirurgisesti. Hoidon tehoa arvioidaan kirurgisen poiston jälkeen histopatologisesti ja käyttämällä immunohisto-kemiallisia värjäyksiä.
    E.2.2Secondary objectives of the trial
    To evaluate delayed skin reactions after photodynamic treatment. To investigate occurrence of TERT-mutations in Lentigo maligna.
    Arvioida fotodynaamisen hoidon aiheuttamia jälkireaktioita hoitoalueella. Tutkia TERT-mutaatioiden esiintymistä Lentigo malignoissa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with non-invasiveLentigo maligna located in the skin of face, neck or upper body region.
    Potilaat, joilla todetaan kasvojen, kaulan tai ylävartalon alueen ei-invasiivinen Lentigo maligna.
    E.4Principal exclusion criteria
    Biopsy shows invasive melanoma inside Lentigo maligna lesion prior treatment. Porfyria or solar dermatitis. Allergy for
    photosensitizers used in study. Pregnant or breastfeeding patients.
    Mikäli ennen hoitoja otetussa koepalassa todetaan invasiivinen melanooma Lentigo malignan alueella. Aiemmin todettu porfyria tai valoihottuma. Allergia käytettävälle
    valoherkistäjälle. Raskaana olevat tai imettävät.
    E.5 End points
    E.5.1Primary end point(s)
    Histopathological curing of Lentigo maligna. Also immunohistochemical stains are used in the assessment of curing.
    Lentigo malignan histopatologinen paraneminen. Myös immunohistokemiallisia värjäyksiä käytetään paranemisen arvioinnissa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after last photodynamic treatment
    4 viikkoa viimeisen fotodynaamisen hoidon jälkeen
    E.5.2Secondary end point(s)
    To assess delayed skin reactions after photodynamic treatment. To investigate occurrence of TERT-mutations in Lentigo maligna. To control the clinical curing of Lentigo maligna after photodynamic and surgical treatment.
    Arvioida fotodynaamisen hoidon aiheuttamia jälkireaktioita iholla. Selvittää TERT-mutaatioiden esiintymistä Lentigo malignoissa. Kontrolloida Lentigo malignan kliininen paraneminen fotodynaamisten ja kirurgisen hoidon jälkeen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 weeks (delayed skin reactions). 4 weeks (TERT-mutations). 6 months (clinical curing).
    2 viikkoa (jälkireaktion arvio). 4 viikkoa (TERT-mutaatiot). 6 kuukautta (kliinisen paranemisen kontrolli).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    prospektiivinen tapaussarja
    prospective case series
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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 patient data is planned to be collected during 2016-2017 and thus
    the study is supposed to be finished by the end of the year 2018.
    Potilasaineisto on tarkoitus kerätä vuosien 2016-2017 aikana, jolloin
    tutkimus saataisiin päätökseen vuoden 2018 loppuun mennessä.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    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 state15
    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)
    In the study there is included one clinical control 6 months after surgical treatment. If the patients would need follow-up after that or further treatment of Lentigo maligna or other skin lesions after study's end, it will be arranged in
    the dermatological clinic of Päijät-Hämeen keskussairaala.
    Tutkimukseen kuuluu yksi kliininen kontrollikäynti 6 kuukauden kuluttua kirurgisesta hoidosta. Jos tutkimukseen osallistuvat potilaat tarvitsevat Lentigo malignan tai muiden ihomuutosten jatkoseurantaa tai hoitoa tutkimuksen päättymisen jälkeen, niin jatkoseuranta ja tarvittavat hoidot
    järjestetään Päijät-Hämeen keskussairaalan ihotautipoliklinikalla.
    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 Decision2015-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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