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    Summary
    EudraCT Number:2013-000778-31
    Sponsor's Protocol Code Number:VITAMINAD
    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:2013-07-10
    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 number2013-000778-31
    A.3Full title of the trial
    Role of Vitamin D in maintaining the integrity of epidermal barrier in
    psoriatic skin
    Ruolo della Vitamina D nel mantenimento dell'integrità della barriera
    epidermica nella cute psoriasica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin D and Psoriasis
    Vitamina D e Psoriasi
    A.4.1Sponsor's protocol code numberVITAMINAD
    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 SponsorCLINICA DERMATOLOGICA POLICLINICO UMBERTO I "SAPIENZA"
    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 supportAssociazione Romana Ricerca Dermatologica
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStefano Calvieri
    B.5.2Functional name of contact pointStefano Calvieri
    B.5.3 Address:
    B.5.3.1Street AddressViale del Policlinico 155
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number00390649976901
    B.5.5Fax number0039064462104
    B.5.6E-mailstefano.calvieri@uniroma1.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 DAIVONEX
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S, 55 Industriparken - 2750 Ballerup (Danimarca)
    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.3.1Product nameDAIVONEX
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typeCalcipotriol
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriatic skin
    Cute psoriasica
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Psoriasi
    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
    Role of Vitamin D in maintaining the integrity of epidermal barrier in
    psoriatic skin
    Ruolo della Vitamina D nel mantenimento dell'integrità della barriera
    epidermica nella cute psoriasica
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Males and females aged between 18 and 65 years
    -Psoriasis with mild to moderate involvement of the body surface less than 50%
    -Written informed consent
    -Pazienti di sesso maschile e femminile di età compresa tra 18 e 65
    anni
    -Psoriasi lieve -moderata con coinvolgimento della superficie corporea inferiore al 50%
    -Consenso informato scritto
    E.4Principal exclusion criteria
    -Use of topical vitamin D in the last six months
    -Systemic use of vitamin D in the last six months
    -Use of traditional or biological systemic therapies in the last six months
    -Fertile patients that don't make use of safe contraceptives methods
    -Pregnancy and/or lactation
    -Participation in other clinical trials in the last six months
    -Alcoholism
    -Drug dependence
    -Poor compliance
    -uso di analoghi topici della vitamina D negli ultimi sei mesi
    -uso sistemico di preparati a base di vitamina D negli ultimi sei mesi
    -uso di terapie sistemiche tradizionali o biologiche negli ultimi sei mesi
    -pazienti in età ferile che non fanno uso di metodi contraccetivi sicuri
    -gravidanza e/o allattamento
    -partecipazione ad altri studi clinici negli ultimi sei mesi
    -alcolismo
    -farmaco-dipendenza
    -scarsa compliance
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate the possible role of vitamin D in maintaining the integrity of
    epidermal barrier in psoriatic skin
    Valutare il possibile ruolo della vitamina D nel mantenimento
    dell'integrità della barriera epidermica nella cute psoriasica
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 days
    60 giorni
    E.5.2Secondary end point(s)
    Evaluate the ability of vitamin D analogs to modify the expression of
    receptors ( VDR,TLRs ), the production of antimicrobial peptides, the expression and localizzation of junctional proteins.
    Valutare la capacità degli analoghi della vitamina D di modificare
    l'espressione recettoriale ( VDR, TLRs ), la produzione di peptidi
    antimicrobici, l'espressione e la localizzazionde delle proteine
    giunzionali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 days
    60 giorni
    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 Yes
    E.6.6Pharmacokinetic No
    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) 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 Yes
    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 Yes
    E.8.2.3Other No
    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
    Role of Vitamin D in psoriasis
    Ruolo della Vitamina D nella psoriasi
    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 months
    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: 40
    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 Yes
    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 state40
    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)
    None
    Nessuno
    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 Decision2013-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-11
    P. End of Trial
    P.End of Trial StatusOngoing
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