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    Summary
    EudraCT Number:2013-005438-39
    Sponsor's Protocol Code Number:40736
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-03-17
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-005438-39
    A.3Full title of the trial
    Pulse photodynamic therapy with methyl aminolevulinate activated by a halogen lamp
    Puls-fotodynamisk terapi med methylaminolevulinat aktiveret ved halogenlampe
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of precursors to skin cancer with photodynamic therapy using a halogen lamp
    Lys-terapi med halogenlampe til behandling af forstadier til hudkræft
    A.4.1Sponsor's protocol code number40736
    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 SponsorDepartment of Dermatology D92, Bispebjerg Hospital
    B.1.3.4CountryDenmark
    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 supportDermatologcial department D92, Bispebjerg Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Bispebjerg Hospital
    B.5.2Functional name of contact pointDepartment of Dermatology
    B.5.3 Address:
    B.5.3.1Street AddressBispebjerg Bakke 23
    B.5.3.2Town/ cityKøbenhavn NV
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number00453531 3155
    B.5.6E-mailHans.Christian.Olsen.Wulf@regionh.dk
    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 Metvix
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma Nordic AB
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethyl aminolevulinate
    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 mg/g
    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
    Actinic keratoses
    Aktiniske keratoser
    E.1.1.1Medical condition in easily understood language
    Precursors to skin cancer
    Solskader som kan udvikle sig til hudkræft
    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 16.1
    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
    To investigate the effect of indoor pulse photodynamic therapy in the treatment of actinic keratoses with a halogen lamp
    At undersøge effekten af indendørs dagslys puls-PDT ved behandling af aktiniske keratoser med halogenlampe
    E.2.2Secondary objectives of the trial
    To investigate the following:
    Failure rate (recurrence)
    Pain during treatment
    Adverse effects: Scaring, hypo- and hyperpigmentation, erythema
    Cosmetic outcome
    Effect of the halogen lamp to activate PpIX in normal skin
    Undersøge følgende:
    Recidivfrekvens
    Smerte under PDT behandlingen
    Rødme og sårdannelse
    Ar, hyper- og hypopigmentering
    Kosmetisk resultat
    Effekt af halogenlampe til at aktivere PpIX
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Scandinaivan ancestory
    Healthy individuals
    Actinic keratoses in forehead or scalp
    18 years old og older
    Infomed written and oral consent
    No nevi, tatoos or scars in the treated areas
    Fertile women have to use safe contraceptive measures
    Medical record with regards to medical treatment is mandatory before inclusion
    · Skandinavisk afstamning
    · Raske individer
    · 18 år eller ældre
    · Informeret mundtligt og skriftligt samtykke
    · Ingen modermærker, tatoveringer eller ar i behandlingsområderne
    · Fertile kvinder skal anvende sikker antikonception (p-piller, p-sprøjte, p-stav, p-ring, p-plaster, spiral eller sterilisation)
    · Der skal foreligge medicinstatus ved undersøgelsens start
    E.4Principal exclusion criteria
    Allergy to Methyl-ALA
    · Vacation in a sunny environment or use og sunbed within last 4 weeks.
    Relevant active skin disease in treatment area
    · Decreased skin sensitivity, like neuropathy
    · Pregnancy or breastfeeding
    · Concurrent participation in other clinical trials
    · Patients thought not to be able to follow protocol ie patients with dementia, psychiatric illnesses, alcoholics
    · Allergi over for Methyl-ALA
    · Solferie eller brug af solarium inden for de sidste 4 uger.
    · Relevant aktiv hudsygdom i behandlingsområdet
    · Nedsat hudsensitivitet, såsom perifer neuropati
    · Graviditet og amning
    · Aktuel deltagelse i andre kliniske forsøg
    · Patienter som ikke skønnes at ville kunne følge behandlingsprotokollen (f.eks. demente, psykisk syge, alkoholiserede m.fl.)
    - Patienter på 18 år eller derover
    E.5 End points
    E.5.1Primary end point(s)
    Clearance rate 3 months after treatment. It is assessed whether the lesion is completely disappeared after treatment(complete response) or not completely disappeared (non-complete response)
    Klinisk behandlingsrespons efter 3 måneder. Det vurderes om læsionen er fuldstændig forsvundet ved behandlingen (complete response) eller ikke helt forsvundet ved behandlingen (non-complete response)
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 måneder
    E.5.2Secondary end point(s)
    Failure rate (recurrence)
    Pain during photodynamic therapy
    Adverse effect: scaring, hypo- and hyperpigmentation, erythema
    Cosmetic outcome
    Effect of the halogen lamp to activate PpIX in normal skin
    Recidivfrekvens
    Smerte under PDT behandlingen
    Rødme og sårdannelse
    Ar, hyper- og hypopigmentering
    Kosmetisk resultat
    Effekt af halogenlampe til at aktivere PpIX
    E.5.2.1Timepoint(s) of evaluation of this end point
    Failure rate (relapse) : 6 and 12 months
    Pain during photodynamic therapy: every 30 minutes during exposure to light and 4 different timepoints the day after treatment
    Adverse effect: erythema and wound - 2 days after treatment
    Scarring, hyper and hypopigmentation: 3, 6 and 12 months after treatment
    Cosmetic outcome: 3 and 12 months after treatment
    Effect of the halogen lamp: imediately after exposure to light ie 2 hours
    Recidivfrekevns: 6 og 12 måneder

    Smerte: Patienter vil få udleveret en smertedagbog hvori de skal score smerten i behandlingsområdet hver halve time under lyseksponering, samt ved 4 fastsatte tidspunkter dagen efter behandlingen.

    Rødme og sårdannelse: 2 dage efter behandling

    Ar, hyper- og hypopigmentering: Evalueres af investigator 3, 6 og 12 måneder

    Kosmetisk resultat: 3 og 12 måneder efter behandling

    Effekt af halogenlampe: umiddelbart efter belysning dvs. 2 timer
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 Yes
    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
    Split face
    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
    To lyskilder sammenlignes
    To light sources are compared
    E.8.2.4Number of treatment arms in the trial2
    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
    LVLS
    Studiet slutter med opfølgning 12 måneder efter behandling.
    Har patienten stadig behandlingskrævende hudsygdom tilbydes denne at fortsætte i vort ambulatorium til videre behandling, alternativt hos praktiserende speciallæge
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state28
    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)
    If the patients still have actinic keratoses in the treated areas they are offered standard treatment in our dermatological department - ie follow national guidelines
    Såfremt patienter stadig har aktiniske keratoser ved forsøgets afslutning, da overgår de til normal kontrol og behandling på hudafdelingen eller hos privatpraktiserende dermatolog. Således følge nationale guidelines
    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 Decision2014-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-04-01
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