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    Summary
    EudraCT Number:2016-000409-35
    Sponsor's Protocol Code Number:1069_OPBG_2016
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-03-15
    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 number2016-000409-35
    A.3Full title of the trial
    Explorative study on the clinical efficacy and tolerability of methylprednisolone aceponate cream and a new topical medical device in paediatric patients with mild to moderate Atopic Dermatitis, testing two different application modalities in the same patient on flexural contralateral lesions.
    Studio Esplorativo sull’Efficacia e la Tollerabilità di una Crema a base di Metilprednisolone Aceponato ed un Nuovo Dispositivo Medico Topico in Pazienti Pediatrici con Dermatite Atopica Lieve o Moderata, attraverso la Valutazione di Due Differenti Modalità di Applicazione nello Stesso Paziente su Lesioni Controlaterali Flessurali.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Explorative study on the clinical efficacy and tolerability of methylprednisolone aceponate cream and a new topical medical device in paediatric patients with mild to moderate Atopic Dermatitis, testing two different application modalities in the same patient on flexural contralateral lesions.
    Studio Esplorativo sull’Efficacia e la Tollerabilità di una Crema a base di Metilprednisolone Aceponato ed un Nuovo Dispositivo Medico Topico in Pazienti Pediatrici con Dermatite Atopica Lieve o Moderata, attraverso la Valutazione di Due Differenti Modalità di Applicazione nello Stesso Paziente su Lesioni Controlaterali Flessurali.
    A.4.1Sponsor's protocol code number1069_OPBG_2016
    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 SponsorBambino Gesù Children's Hospital
    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 supportBayer S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPBG CRO
    B.5.2Functional name of contact pointValeria Antenucci
    B.5.3 Address:
    B.5.3.1Street AddressViale Ferdinando Baldelli 41
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00146
    B.5.3.4CountryItaly
    B.5.4Telephone number00390668593539
    B.5.6E-mailvaleria.antenucci@opbg.net
    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 Bepanthenol Sensiderm®
    D.2.1.1.2Name of the Marketing Authorisation holderBayer 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 nameBepanthenol Sensiderm®
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    D.3.11.13.1Other medicinal product typeMedical Device
    D.IMP: 2
    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.2.5The 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 nameMethylprednisolone aceponate
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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
    Atopic Dermatitis
    Dermatite Atopica
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory disease of the skin
    Malattia infiammatoria cronica della pelle
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    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
    Objective of the study is to evaluate the effects of treatment with methylprednisolone aceponate and Bepanthenol Sensiderm® with two different application modalities on the AD clinical course in pediatric patients with mild to moderate AD.
    Valutare gli effetti del trattamento concomitante con una crema a base di Metilprednisolone Aceponato e Bepanthenol Sensiderm® utilizzati secondo due differenti modalità di applicazione, su lesioni di bambini affetti da Dermatite Atopica lieve o moderata, in fase acuta.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Children >2 and <14 years old, both sexes;
    • Diagnosis of mild to moderate atopic dermatitis evaluated by means of the SCORAD index (10); SCORAD index have to be < 40;
    • Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and  12) at Baseline;
    • Acute symptom of pruritus at enrollment (Visit 1);
    • Patients who will be enrolled should not have been on treatment with any emollient medical device for continuous period greater than 20 days;
    • Ability of the participant/parents/legal guardians (in the Investigator’s opinion) to comprehend the full nature and purpose of the study;
    • Consent to the study and willing to comply with all its procedures.
    1. Bambini, di entrambi i sessi, di età >2 e <14 anni;
    2. Diagnosi di Dermatite Atopica lieve o moderata mediante l’indice SCORAD; tale indice deve essere <40.
    3. Sintomi di Dermatite Atopica in fase acuta su ciascuna area di valutazione (indice SCORAD locale ≥ 3 and  12) al basale.
    4. Sintomi acuti di prurito all’arruolamento (Visit 1);
    5. I soggetto che saranno arruolati non dovranno essere stati in trattamento con alcun dispositivo medico a base di emollienti per un periodo continuativo maggiore a 20 giorni;
    6. Capacità da parte dei soggetti partecipanti o dei genitori o dei rappresentanti legali (secondo il giudizio dello sperimentatore) di comprendere la natura e lo scopo dello studio;
    7. Ottenimento del consenso scritto allo studio e disponibilità al rispetto di tutte le sue procedure.
    E.4Principal exclusion criteria
    • Patients with oozing/crusting lesions
    • Chronic disease (autoimmune diseases, Chronic Obstructive Pulmonary Disease (COPD), heart disease, Chronic Renal Failure (CRF), Central Nervous System (CNS) disease, diabetes, congenital or acquired immunodeficiency;
    • Known hypersensitivity or allergies to any components of the study products;

    • Acute or chronic infectious diseases;
    • Local therapy with corticosteroid or tacrolimus, pimecrolimus in the previous 6 weeks;
    • Use of any prescription or non-prescription medication prior to baseline that could interfere with evaluations in the study
    • Systemic corticosteroids within 8 weeks
    • Systemic retinoids within 4 weeks
    • Non-steroidal immunosuppressive treatment within 4 weeks
    • Topical antibiotics, topical corticosteroids and/or topical retinoids within 2 weeks
    • Participation in another clinical research study within 4 weeks before enrollment in this study
    • Relatives of the investigator or site staff
    1. Soggetti che presentino lesioni essudative o con croste;
    2. Presenza di malattie croniche (malattie autoimmuni, broncopneumopatia cronica ostruttiva, malattie cardiache, insufficienza renale cronica, malattie del sistema nervoso centrale, diabete, immunodeficienza congenita o acquisita;
    3. Ipersensibilità o allergie note a qualsiasi componente dei prodotti in studio;
    4. Malattia infettiva acuta o cronica;
    5. Terapia locale con corticosteroidi, tacrolimus o pimecrolimus, nelle 6 settimane precedenti;
    E.5 End points
    E.5.1Primary end point(s)
    The exploratory efficacy variables will be assessed at every assessment area of each patient before and during treatment.
    The following outcomes will be evaluated:
    • any SCORAD change since day 0 to day 28±2;
    • any PO-SCORAD change since day 0 to day 28±2;
    • any LOCAL SCORAD change since day 0 to day 28±2;
    • QoL change since day 0 to day 28±2;
    • symptoms (itching) change since day 0 to day 28±2;
    • Incidence of AEs and SAEs.
    • Vital signs (blood pressure, heart rate, body temperature);
    • percentage of patients that applied Bepanthenol Sensiderm® more than once a day
    average number of extra application of Bepanthenol Sensiderm® per patient
    Le variabili di efficacia saranno valutate, per le aree designate di ciascun paziente, prima e durante il trattamento, secondo le seguenti modalità e i seguenti timpoints:
    - qualsiasi cambiamento nell’indice SCORAD dal Giorno 0 al Giorno 28 ± 2;
    - qualsiasi cambiamento nell’indice PO-SCORAD dal Giorno 0 al Giorno 28 ± 2;
    - qualsiasi cambiamento nell’indice LOCAL SCORAD dal Giorno 0 al Giorno 28 ± 2;
    - cambiamento nel punteggio del questionario sulla Qualità della Vita dal Giorno 0 al Giorno 28 ± 2;
    - cambiamento nei sintomi (prurito) dal Giorno 0 al Giorno 28 ± 2;
    - incidenza di Eventi avversi seri e non seri;
    - segni vitali (pressione sangugna, frequenza cardiaca, temperatura corporea);
    - percentuale di pazienti che hanno applicato Bepanthenol Sensiderm® più di una volta al giorno e media delle applicazioni extra di Bepanthenol Sensiderm® per ciascun paziente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 to day 28±2
    Dal Giorno 0 al Giorno 28 ± 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 No
    E.8.1.1Randomised No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    LVLP
    Ultima visita dell'ultimo paziente
    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
    E.8.9.2In all countries concerned by the trial months12
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    Bambini
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 Decision2016-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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