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    Summary
    EudraCT Number:2016-000490-20
    Sponsor's Protocol Code Number:Galderma-Metvix
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-000490-20
    A.3Full title of the trial
    Evaluation of efficacy, safety and patient¿s satisfaction of daylight photodynamic therapy (DL-PDT) in the treatment of actinic keratosis on the face and scalp and related field cancerization carried out with two different skin preparation modalities
    Evaluation of efficacy, safety and patient¿s satisfaction of daylight photodynamic therapy (DL-PDT) in the treatment of actinic keratosis on the face and scalp and related field cancerization carried out with two different skin preparation modalities
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Daylight photodynamic therapy (DL-PDT) in the treatment of actinic keratosis on the face and scalp carried out with two different skin preparation modalities
    Terapia fotodinamica daylight per il trattamento delle cheratosi attiniche del viso e del cuoio capelluto in seguito a due differenti modalit¿ di preparazione della cute
    A.3.2Name or abbreviated title of the trial where available
    Daylight photodynamic therapy (DL-PDT) in the treatment of actinic keratosis on the face and scalp c
    Terapia fotodinamica daylight per il trattamento delle cheratosi attiniche del viso e del cuoio cape
    A.4.1Sponsor's protocol code numberGalderma-Metvix
    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 SponsorA.O.U. Università degli Studi della Campania "Luigi Vanvitelli"
    B.1.3.4CountryItaly
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReparto di Dermatologia- Seconda Universit¿ degli Studi di Napoli
    B.5.2Functional name of contact pointClinica Dermatologica
    B.5.3 Address:
    B.5.3.1Street AddressVia Pansini 5
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number0815666828
    B.5.5Fax number0815468759
    B.5.6E-maildermosun@gmail.com
    D. IMP Identification
    D.IMP: 1
    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 - TUBO DA 2 DI CREMA 160 MG/G
    D.2.1.1.2Name of the Marketing Authorisation holderGALDERMA ITALIA S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.1Product namemetil aminolevulinato
    D.3.2Product code MAL
    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 INNMETILAMINOLEVULINATO
    D.3.9.1CAS number 33320-16-0
    D.3.9.2Current sponsor codeMAL
    D.3.9.3Other descriptive namemethyl 5-aminolevulinate
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 keratosis
    Cheratosi attiniche
    E.1.1.1Medical condition in easily understood language
    Prevention of Skin Cancers
    Prevenzione tumori della cute
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10064679
    E.1.2Term Basal cell carcinoma of skin in situ
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10064266
    E.1.2Term Skin hemorrhage
    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 main objective of this study to evaluate and compare efficacy (based on clinical, dermoscopic and confocal assessments), safety and patient¿s satisfaction of DL-PDT in the treatment of AKs on the face and scalp and related field cancerization carried out with two different skin preparation modalities.
    L'obiettivo principale di questo studio ¿ quello di valutare e comparare l¿efficacia (riscontrata mediante valutazioni cliniche, dermoscopiche e di microscopia confocale), la sicurezza e la soddisfazione del paziente riguardo la terapia fotodinamica daylight nel trattamento delle cheratosi attiniche di viso/cuoio capelluto e del relativo campo di cancerizzazione in seguito all¿utilizzo di due differenti modalit¿ di preparazione della cute.
    E.2.2Secondary objectives of the trial
    Patient compliance and assessment of safety and local tolerability to treatment.
    Compliance del paziente e valutazione della sicurezza e della tollerabilit¿ locale al trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult patients with AK lesions on face or scalp (at least 3 AKs on scalp, forehead or cheek)
    • AKs of grade I to II
    • 18 Years and older
    - pazienti adulti con cheratosi attiniche su viso e cuoio capelluto (almeno 3 cheratosi su cuoio capelluto, fronte o guancie)
    - cheratosi attiniche di grado I e II
    - maggiore di 18 anni
    E.4Principal exclusion criteria
    • Previous treatment for AKs on the same skin area during preceding 6 months
    • Porphyria or solar dermatitis
    • Morpheaform BCC
    • Allergy for photosensitizers used in the study
    • Pregnant or breastfeeding patients
    • Impaired general condition (patient can't manage required 2 hours in sunlight outdoors)
    - Trattamenti precedenti per cheratosi attiniche presenti nelle stesse aree nei precedenti 6 mesi
    - Porfiria o dermatite solare
    - BCC morfeiforme
    - Allergia ai fotosensibilizzanti utilizzati nello studio
    - Gravidanza o allattamento
    - Condizioni generali deteriorate (il paziente non può tollerare esposizione al sole richiesta di 2 ore)
    E.5 End points
    E.5.1Primary end point(s)
    • Total count of AKs before and after treatment [Time Frame: baseline and week 13]. AKs in the treatment areas are counted, categorized clinically in three grades I-III (Olsen et al. 1991), and examined dermoscopically and confocally before DL-PDT treatment. The response to treatment will be assessed clinically, dermoscopically and confocally on week 13.
    • Patient satisfaction assessed by a questionnaire [Time Frame: weeks 2 and 13]. Patients will be asked to fill 5-point Likert scale about satisfaction to treatment .
    - Conto totale delle cheratosi attiniche prima e dopo il trattamento. Le cheratosi attiniche nelle aree di trattamento saranno contate, categorizzate clinicamente in 3 gradi da I a III (Olsen et al. 1991), esaminate dermoscopicamente e mediante microscopia confocale prima del trattamento con daylight-PDT. La risposta al trattamento sarà valutata clinicamente, dermoscopicamente e mediante microscopia confocale alla settimana 13.
    - Soddisfazione del paziente valutata mediante un questionario (settimane 2 e 13). Ai pazienti verrà chiesto di compilare un questionario (5-point Likert scale) circa il grado di soddisfazione al trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    13 weeks
    13 settimane
    E.5.2Secondary end point(s)
    ¿ Assessing pain experienced by patients [Time Frame: weeks 1 and 2]. Patients will be asked to fill visual analogue scales (VAS) about pain experienced during the treatment.
    ¿ Assessing safety and primary treatment reaction of skin [Time Frame: weeks 1 and 2]. Patients will be evaluated after treatment for evaluation of skin reaction (erythema, scaling, pigmentation, follicular plugs) on a scale ranging from 0 (no reaction) to 4 (very severe reaction). Primary treatment reaction of skin will be assessed after the DL-PDT treatment.
    - Valutazione del dolore sperimentato dal paziente (settimane 1 e 2). Ai pazienti ¿ richiesto di compilare un questionario analogico visivo riguardo il dolore sperimentato durante il trattamento.
    - Valutazione della sicurezza e delle reazioni della cute al trattamento (settimane 1 e 2). I pazienti saranno valutati alla fine del trattamento per la comparsa di reazioni cutanee (eritema, squame, pigmentazione, tappi cheratinici follicolari) su una scala da 0 (nessuna reazione) a 4 (reazione molto grave).
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 1 and 2
    settimana 1 e settimana 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) 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 Yes
    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 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
    I pazienti saranno randomizzati in due gruppi in base alla modalit¿ di preparazione della cute (effe
    Patients will be randomized in two groups (skin preparation by curettage before DL-PDT performed in
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA2
    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 Information not present in EudraCT
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    At the end of this study, patients will be visited periodically in dermatological ambulatories.
    Ai pazienti che partecipano allo studio sar¿ consigliato di praticare periodici controlli clinici presso l'ambulatorio di dermatologia una volta terminato lo studio.
    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 Decision2018-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-22
    P. End of Trial
    P.End of Trial StatusOngoing
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