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    Summary
    EudraCT Number:2014-005121-13
    Sponsor's Protocol Code Number:Daylight_01
    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:2015-02-19
    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 number2014-005121-13
    A.3Full title of the trial
    Prospective, randomized, controlled, multicenter, two-armed, study comparing daylight photodynamic therapy using MAL with cryosurgery for the treatment and prophylaxis of actinic keratoses in photodamaged skin of the face
    Prospektive, randomisierte, kontrollierte, multizentrische, zweiarmige, Studie zur Tageslicht-PDT mit Methylaminolevulinat im Vergleich zur Kryochirurgie für die Behandlung und Prophylaxe von aktinischen Keratosen bei lichtgeschädigter Haut im Gesicht
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study comparing daylight photodynamic therapy with cryosurgery for the treatment and prophylaxis of actinic keratoses in photodamaged skin of the face
    Klinische Studie zur Tageslicht-PDT im Vergleich zur Kryochirurgie für die Behandlung und Prophylaxe von aktinischen Keratosen bei lichtgeschädigter Haut im Gesicht
    A.3.2Name or abbreviated title of the trial where available
    Daylight-PDT with MAL for AK and photodamaged skin
    A.4.1Sponsor's protocol code numberDaylight_01
    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 SponsorUniversity Hospital Regensburg
    B.1.3.4CountryGermany
    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 supportGalderma Laboratorium GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Regensburg
    B.5.2Functional name of contact pointKlinik für Dermatologie Regensburg
    B.5.3 Address:
    B.5.3.1Street AddressFranz-Josef-Strauß-Allee 11
    B.5.3.2Town/ cityRegensburg
    B.5.3.3Post code93053
    B.5.3.4CountryGermany
    B.5.4Telephone number00499419449656
    B.5.5Fax number00499419449657
    B.5.6E-mailsigrid.karrer@ukr.de
    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 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 IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYL AMINOLEVULINATE HYDROCHLORIDE
    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.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 and photoaged skin
    Aktinische Keratosen und lichtgeschädigte Haut
    E.1.1.1Medical condition in easily understood language
    Actinic keratoses and photoaged skin
    Aktinische Keratosen und lichtgeschädigte Haut
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    The primary aim of the study is the evaluation of the efficacy of daylight- PDT with MAL in the treatment and prophylaxis of AKs in the face compared to cryosurgery
    Studienziel ist die Evaluation der Effektivität der Tageslicht-PDT mit MAL für die Behandlung und Prophylaxe von aktinischen Keratosen im Gesicht im Vergleich zu Kryochirurgie
    E.2.2Secondary objectives of the trial
    Evaluation of the efficacy on lesion basis
    Evaluation of the efficacy on patient basis
    Evaluation of the efficacy for the improvement of photodamaged skin
    Evaluation of the tolerability
    Evaluation of the safety
    Prevention of newly formed AKs
    Evaluation of patient satisfaction with cosmetic results
    Evaluation of investigators’ satisfaction with cosmetic results
    Evaluation of skin-related quality of life
    Evaluation der Effektivität auf Patientenbasis
    Evaluation der Effektivität für die Verbesserung lichtgeschädigter Haut
    Evaluation der Tolerabilität
    Evaluation der Sicherheit
    Prävention von neuer aktinischer Keratosen
    Evaluation der Patientenzufriedenheit mit dem kosmetischen Ergebnis
    Evaluation der Zufriedenheit der Investigatoren mit dem kosmetischen Ergebnis
    Evaluation der hautbezogenen Lebensqualität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent has been signed prior to or at Screening Visit
    Male and female patients with Fitzpatrick skin type I-IV
    Age > 40 years
    Negative pregnancy test in women of childbearing age
    Women in child-bearing age using highly efficient contraceptive methods (<1% failure rate per
    year)
    Clinical diagnosis of actinic keratosis (AK)
    A minimum of five non-hyperkeratotic, non-pigmented AK lesions in the face.
    Glogau Photodamage Classification Type II (moderate) – IV (severe)
    Schriftliche Einverständniserklärung
    Männliche und weibliche Patiennten mit Fitzpatrick Hauttyp I-IV
    Alter > 40 Jahre
    Negativer Schwangerschaftstest bei Frauen im gebärfähigem Alter
    Frauen im gebärfähigem Alter müssen eine hocheffektive Kontrazeptionsmethode (Versagerrate <1% pro Jahr) anwenden
    Mindestens 5 nicht-hyperkeratotische, nicht-pigmentierte aktinische Keratosen im Gesicht
    Glogau Klassifikation Typ II (moderat) - IV (schwer)
    E.4Principal exclusion criteria
    Diagnosis of porphyria
    Hyperkeratotic or pigmented AK in the face
    Malignant skin tumors in the face or on the capillitium, requiring treatment
    Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection) or organ transplant patients
    Pregnancy or lactation
    Planned aesthetic treatments in the face in the next 24 months (filler, peeling, botulinumtoxin, skin resurfacing)
    Known intolerance or allergy to MAL or to any other ingredient of Metvix® 160mg/g cream
    Known intolerance to Actinica® lotion
    Photosensitivity
    Suspected lack of compliance (e.g. due to dementia)
    Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
    Concomitant UV-phototherapy
    Skin diseases that might interfere with response evaluation of study treatment
    Skin sun sensitivity type V or VI according to Fitzpatrick
    PDT in the face during 6 months preceding study treatment
    Non-permitted medication:
    Topical treatment in the face during 4 weeks preceding study treatment with diclofenac, hydrochinone, peeling, 5-FU, ingenolmebutate, retinoids, podophyllin, azelaic acid, imiquimod or other agents, that could interfere with the evaluation of the efficacy of the study treatment, according to the investigator.
    Systemic treatment with retinoids
    Conditions that might interfere with the ability to understand the study and thus give written informed consent
    Rejuvenating treatments of the face during 3 months preceding study treatment, including filler, botulinumtoxin and IPL
    Porphyrie
    Hyperkeratotische und pigmentierte AKs im Gesicht
    Aktuell behandlungsbedürftige maligne Hauttumoren im Gesicht/Kopf (außer AK)
    Patienten mit klinisch relevanter Suppression des Immunsystems (medikamenteninduziert, Infektion)
    Schwangerschaft oder Stillzeit
    Geplante ästhetische Behandlungen im Gesicht in den nächsten 24 Monaten (Filler, Peeling, Botulinumtoxin, Resurfacing)
    Bekannte Intoleranz oder Allergie gegenüber MAL oder anderen Inhaltsstoffen von Metvix® 160mg/g Creme
    Bekannte Intoleranz gegenüber Actinica® lotion
    Photosensitivität
    Incompliance (z.B. Demenz)
    Gleichzeitige Teilnahme an einer anderen Studie oder gleichzeitige Teilnahme an einer anderen klinischen Studie 30 Tage vor Studieneinschluss
    Gleichzeitige Lichttherapie
    Hauterkrankungen, die mit der Beurteilung des Therapieergebnisses interferieren
    Hauttyp V oder VI nach Fitzpatrick
    PDT im Gesicht in den 6 Monaten vor der Studienbehandlung
    Nicht-erlaubte Medikation:
    Topische Behandlung im Gesicht während 4 Wochen vor der Studienbehandlung mit Diclofenac, Hydrochinon, Peeling, 5-FU, Ingenolmebutat, Retinoiden, Podophyllin, Azelainsäure und Imiquimod sowie Substanzen, die mit der Evaluation der Effektivität interferieren könnten.
    Systemische Therapie mit Retinoiden
    Unfähigkeit den Inhalt der Studie zu erfassen und demzufolge das schriftliche Einverständnis zu erklären
    Hautverjüngende Behandlungen im Gesicht während der drei Monate vor der Studienbehandlung, einschließlich Filler, Botulinumtoxin und IPL
    E.5 End points
    E.5.1Primary end point(s)
    The cumulative number of AKs (sum of all AKs from visit 2 to visit 6) is defined as the primary endpoint.
    Kumulative Anzahl von aktinischen Keratosen bei den Visiten 2-6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits 2-6
    Visiten 2-6
    E.5.2Secondary end point(s)
    Evaluation of the efficacy on lesion basis
    Evaluation of the efficacy on patient basis
    Evaluation of the efficacy for the improvement of photodamaged skin
    Evaluation of the tolerability
    Evaluation of the safety
    Evaluation of patient satisfaction with cosmetic results
    Evaluation of investigators’ satisfaction with cosmetic results
    Evaluation of skin-related quality of life
    Evaluation der Effektivität auf Läsionsbasis
    Evaluation der Effektivität auf Patientenbasis
    Evaluation der Effektivität in der Verbesserung lichtgeschädigter Haut
    Evaluation der Tolerabilität
    Evaluation der Sicherheit
    Evaluation der Patientenzufriedenheit mit dem kosmetischen Ergebnis
    Evaluation der Zufriedenheit der Investigatoren mit dem kosmetischen Ergebnis
    Evaluation der hautbezogenen Lebensqualität
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits 2-6
    Visiten 2-6
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Kryochirurgie
    Cryosurgery
    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 concerned5
    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
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 state58
    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 study termination, patients with persisting actinic keratoses will - upon request - continue to be adequately treated with various available therapy options. The Department of Dermatology at the University Hospital Regensburg as well as the other study centres will remain to be the main point of contact for the patients, even after the termination of the study.
    Nach Beendigung der Studie werden die Patienten bei weiter bestehenden aktinischen Keratosen auf Wunsch weiterhin adäquat mit den verschiedenen zur Verfügung stehenden Therapiemöglichkeiten behandelt. Auch nach der Studie bleibt die Klinik und Poliklinik für Dermatologie, Universitätsklinikum Regensburg sowie die weiteren Studienzentren der Ansprechpartner der Patienten.
    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 Decision2015-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-07
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