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    Summary
    EudraCT Number:2016-002088-33
    Sponsor's Protocol Code Number:PER-DIC-16-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 number2016-002088-33
    A.3Full title of the trial
    Impact and Costs of Health Care Education, Phone Reminders and enhanced follow-up intervention on Prescription adherence, Treatment Satisfaction and Effectiveness in patients with Multiple Actinic Keratosis treated with diclofenac in hyaluronic acid gel 3% (Solaraze 3%). No-profit study.
    Impatto e costi di un intervento integrato basato su educazione sanitaria, promemoria telefonici, e follow-up intensificati sull’aderenza, soddisfazione ed efficacia terapeutica in pazienti con cheratosi attinica (AK) in terapia con diclofenac 3% gel in acido ialuronico (Solaraze 3%)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ND
    ND
    A.3.2Name or abbreviated title of the trial where available
    PER-DIC-16-001
    PER-DIC-16-001
    A.4.1Sponsor's protocol code numberPER-DIC-16-001
    A.5.4Other Identifiers
    Name:PER-DIC-16-001Number:PER-DIC-16-001
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    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 supportAlmirall spa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Center SPA
    B.5.2Functional name of contact pointUnità CRO
    B.5.3 Address:
    B.5.3.1Street AddressL.GO GEMELLI 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630157321
    B.5.6E-mailelena.carafelli@clinicaltrialcenter.it
    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 SOLARAZE - "3% GEL" 1 TUBO DA 60 G GEL
    D.2.1.1.2Name of the Marketing Authorisation holderALMIRALL S.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 nameSOLARAZE
    D.3.2Product code [ND]
    D.3.4Pharmaceutical form Gel
    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 INNDICLOFENAC SODICO
    D.3.9.2Current sponsor codeND
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 SOLARAZE - "3% GEL" 1 TUBO DA 60 G GEL
    D.2.1.1.2Name of the Marketing Authorisation holderALMIRALL S.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 nameSOLARAZE
    D.3.2Product code [ND]
    D.3.4Pharmaceutical form Gel
    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 INNDICLOFENAC SODICO
    D.3.9.2Current sponsor codeND
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Multiple Actinic Keratosis
    CHERATOSI ATTINICA
    E.1.1.1Medical condition in easily understood language
    ND
    ND
    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 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 evaluate the efficacy of an integrated low-intensity intervention program against standard-of-care on treatment adherence among patients with multiple AK receiving diclofenac in hyaluronic acid gel 3% (Solaraze 3%).
    Valutare l’efficacia di un intervento integrato a bassa intensità, rispetto all’intervento standard, sull’aderenza alla terapia in pazienti affetti da cheratosi attiniche multiple in terapia con diclofenac 3% gel in acido ialuronico (Solaraze 3%).
    E.2.2Secondary objectives of the trial
    to evaluate the efficacy of an integrated low-intensity intervention program against standard-of-care on:
    - Patient’s complete and partial Lesion Clearance Rate at the end of treatment (3-months);
    - Patient’s complete and partial Sustained Lesion Clearance Rate (at 6- and 12- month);
    - Patient’s Complete Lesion Clearance Rate (at 3-, 6- and 12-month).
    - Treatment Satisfaction at the end of treatment (at 3-month);
    - Impact of AK on Quality of Life (at 3-month);
    - Local Skin Reaction (LSR) score (3-month);
    - Direct Cost of Intervention (at 3-month);
    - To create the content and editing of the educational material and the phone reminder (before RCT starts)
    valutare l’efficacia di un programma di intervento integrato a bassa intensità rispetto alla terapia standard, circa:
    - Il tasso di guarigione completa e parziale della lesione alla fine del trattamento (3 mesi).
    - Il tasso di guarigione completa e parziale della lesione persistente (a 6 e a 12 mesi).
    - Il tasso di guarigione completa della lesione (a 3. 6 e 12 mesi).
    - La soddisfazione dei pazienti per la terapia alla fine del trattamento (a 3 mesi).
    - L’impatto di AK sulla qualità di vita (a 3 mesi).
    - Il punteggio relativo alla valutazione della Reazione Dermica Locale (Local Skin Reaction-LSR) ( a 3 mesi).
    - Il costo diretto dell’intervento (a 3 mesi).
    - Realizzare il contenuto e l’editoria del materiale educativo e del promemoria telefonico (SMS) (prima dell’avvio dello studio clinico).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with clinically typical, visible and discrete multiple AK, grade I/II according to Olsen’s classification, in a skin area of 50 cm2, for whom the treating dermatologist has prescribed diclofenac in hyaluronic acid gel 3% (Solaraze 3%). Those patients should have not started the treatment before the inclusion in the present study .
    2. Willing to participate in the study and able to provide informed consent.
    3. Age = 18 years
    4. Able to read and write in Italian Language
    5. Women with childbearing potential willing not to start a pregnancy during the course f the study and for 1 month after the conclusion of the treatment
    6. Men having relationships with women with childbearing potential willing not to procure a pregnancy during the course of the study and for 1 month after the conclusion of the treatment.
    1. Pazienti adulti affetti da AK clinicamente tipica, visibile, discreta e multipla di grado I/II secondo la classificazione di Olsen, in un’area dermica di 50 cm2, per la quale il dermatologo abbia prescritto una terapia topica con diclofenac 3% gel in acido ialuronico (Solaraze 3%). Quei pazienti non dovrebbero aver iniziato il trattamento prima dell’inclusione nello studio.
    2. Intenzione a partecipare allo studio ed a fornire il consenso informato.
    3. Età = 18 anni
    4. In grado di leggere e scrivere in italiano.
    5. Donne in età fertile che non abbiano intenzione di iniziare una gravidanza durante lo studio e per il mese successivo la conclusione del trattamento.
    6. Uomini che non abbiano intenzione di procurare una gravidanza a donne in età fertile durante lo studio e per il mese successivo la conclusione del trattamento
    E.4Principal exclusion criteria
    1. Unable to understand and execute simple instructions or patients in need of assistance from a caregiver (professional or non-professional) for the application of topical medication.
    2. Patients immunocompromised as per medical history (i.e. iatrogenic immunosuppression, HIV / AIDS)
    3. Any major surgery or major clinical events (i.e. ictus cerebri, myocardial infarction, etc) in the month prior to screening (may affect Patient-Reported Outcomes)
    4. Previous treatments with field-directed therapy in the past 3 months before the screening.
    5. Aspirin-sensitive patients, due to possible cross-reactivity with diclofenac in hyaluronic acid gel 3% (Solaraze %).
    6. Pregnant and breast-feeding women
    7. Forecast of moving to another region within the next 12 months following the potential inclusion in the study.
    1. Incapacità di comprendere ed eseguire semplici istruzioni o pazienti che necessitino di assistenza da parte di un badante (professionale o non-professionale) per l’applicazione del farmaco topico.
    2. Pazienti immunocompromessi come da storia medica (es. immunodepressione iatrogenica, HIV/AIDS, etc).
    3. Qualsiasi intervento di chirurgia importanti o eventi clinici maggiori (es. ictus cerebrale, infarto miocardico, ecc.) nel mese precedente allo screening (può influenzare i relativi Patient Reported Outcomes, ovvero i dati riferiti dl paziente ).
    4. Precedenti trattamenti con terapie dirette al campo di cancerizzazione negli ultimi 3 mesi prima dello screening.
    5. Pazienti intolleranti all’aspirina a causa di possibile cross-reattività con diclofenac 3% gel in acido Ialuronico (Solaraze 3%).
    6. Donne in gravidanza o allattamento.
    7. Previsione di trasferirsi in un’altra regione entro i successivi 12 mesi dalla potenziale inclusione nello studio.
    E.5 End points
    E.5.1Primary end point(s)
    To define the Adherence to the treatment regimen as product use greater than 80% of prescribed dose, and will be calculated according to the Formula: A= [(Wb-We)/Wnb] x 100, where Wb is the gross weight at baseline, We is the gross weight at the end of self-administration, Wnb is the product net nominal weight at baseline.
    l’ aderenza al regime di trattamento sarà definita da un consumo di prodotto maggiore dell’80% rispetto alla dose prescritta secondo A=[(Wb- We)/Wnb] x 100, dove A è la percentuale del peso netto del prodotto usato, Wb è il peso lordo del prodotto al basale e We è il peso lordo del prodotto alla fine del trattamento e Wnb è il peso netto nominale del prodotto consegnato al paziente .
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 Months
    12 mesi
    E.5.2Secondary end point(s)
    1. 3-months Lesion Clearance Rate: the rate of lesion clearance will be defined as the ratio between the number of residual AK lesion count and baseline AK count in the treated area
    2. 6-months and 12-months Sustained Lesion Clearance Rate: the rate of sustained lesion clearance will be defined as the ratio between the number of residual AK lesion count at each time point and baseline AK count in the treated area.
    3. Patient’s Complete Clearance Rate at 3, 6 and 12 months: patient’s complete clearance is defined as clearance of all AK lesions identified at baseline.
    4. Patient’s Partial Clearance Rate at 3, 6 and 12 months: patient’s partial clearance is defined as clearance of 75% of AK lesions identified at baseline.
    5. Treatment Satisfaction on Medication (3 items) (included in the AK QoL)
    6. Quality of Life: AK-QOL questionnaire;
    7. Local Skin Reaction; LSR score will be evaluated with a 6 items scale (Lebowhol et al., 2012).
    8. Intervention Costs per patient. Direct cost will be considered the cost of all medical encounters including extra-visits and phone consultations, health education brochure, sms reminders, product wastage (weight of unused product). The cost incurred for study outcome evaluation (i.e. evaluation of LSR, tube weighting, assessment of lesion clearance) will not be included. Medical encounters will be defined as very short (t<5’), short (5’<t<10’), normal (10’<t<15’), long (15’<t<20’) or very long (t>20’). At the end of each interaction, the attending physicians will record the approximate duration of each visit at first in the ad hoc form and then in the eCRF.
    9. The content and editing of the educational material used for the RCT.
    1. Il tasso di guarigione della lesione a 3 mesi: il tasso di guarigione della lesione sarà definito dal rapporto tra il numero di lesioni attiniche residue e quelle osservate al basale nell’area trattata.
    2. Il tasso di guarigione delle lesioni persistenti a 6 e 12 mesi: il tasso di guarigione delle lesioni persistenti sarà definito dal rapporto tra il numero di lesioni attiniche residue ad ogni visita e quelle osservate al basale nell’area trattata.
    3. Il tasso di completa guarigione a 3, 6 e 12 mesi: la completa guarigione del paziente è definita come la guarigione di tutte le lesioni di AK identificate al basale .
    4. Il tasso di parziale guarigione a 3, 6, e 12 mesi: la parziale guarigione del paziente è definita dalla guarigione del 75% delle lesioni di AK identificate al basale .
    5. La soddisfazione al trattamento medico (3 voci)(inclusi nel questionario AKQOL).
    6. Qualità di Vita: questionario AK-QOL.
    7. Reazione Dermica Locale (LSR): il punteggio LSR sarà valutato con una scala di 6 voci (Lebowhol et al., 2012).
    8. Costi dell’ intervento per paziente: il costo diretto sarà valutato dall’ insieme dei costi relativi ai singoli interventi medici, incluse le visite extra ed i contatti telefonici, la brochure educativa, i promemoria fatti tramite SMS , il prodotto sprecato (peso di prodotto inutilizzato). I costi inerenti la valutazione dei risultati dello studio (es. La valutazione di LSR, la pesatura del prodotto, la valutazione di guarigione della lesione) non saranno inclusi. Gli incontri con il medico saranno definiti come: molto corti (t<5’), corti (5’<t<10’), normali (10’<t<15’), lunghi (15’<t<20’) o molto lunghi (t>20’). Il medico che effettuerà la visita, ne riporterà la durata approssimativa nell’apposito documento fonte e poi nella eCRF ,alla fine di ognuna di queste.
    9. il contenuto e l’editoria del materiale educativo usato per lo studio clinico (RCT).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 MONTHS
    12 MESI
    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 No
    E.6.5Efficacy No
    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
    STESSO FARMACO STESSO DOSAGGIO MA CON DIVERSO MONITORAGGIO CLINICO
    SAME DRUG WITH SAME DOSAGE BUT WITH DIFFERENT MEDICAL MONITORING
    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 concerned6
    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 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 months8
    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 months8
    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: 91
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 91
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-11-04. Yes
    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 state182
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 182
    F.4.2.2In the whole clinical trial 182
    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)
    STANDARD OF CARE
    NORMALE PRATICA CLINICA
    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 Decision2016-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
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