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    Summary
    EudraCT Number:2014-000710-53
    Sponsor's Protocol Code Number:RD.06.SPR.18131
    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:2015-05-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-000710-53
    A.3Full title of the trial
    A multicenter open label uncontrolled study of the long term safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 26 weeks in pediatric subjects (2 to 17 years of age) with mild to moderate plaque psoriasis
    Studio multicentrico, in aperto, non controllato per valutare l'efficacia e la sicurezza a lungo termine di calcitriolo 3 mcg/g unguento applicato applicato due volte al giorno per 26 settimane in soggetti pediatrici (da 2 a 17 anni di età) affetti da psoriasi a placche da lieve a moderata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter open label uncontrolled study of the long term safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 26 weeks in pediatric subjects (2 to 17 years of age) with mild to moderate plaque psoriasis
    Studio multicentrico, in aperto, non controllato per valutare l’efficacia e la sicurezza a lungo termine di calcitriolo 3 mcg/g unguento applicato due volte al giorno per 26 settimane in soggetti pediatrici (da 2 a 17 anni di età) affetti da psoriasi a placche da lieve a moderata
    A.3.2Name or abbreviated title of the trial where available
    Long term safety and efficacy study of calcitriol 3 mcg/g ointment in pediatric subjects with plaque
    Studio sulla sicurezza e efficacia a lungo termine di calcitriolo da 3 mcg/g unguento in soggetti af
    A.4.1Sponsor's protocol code numberRD.06.SPR.18131
    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 SponsorGALDERMA R&D, LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGALDERMA R&D, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGALDERMA R&D, SNC
    B.5.2Functional name of contact pointCTA Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressLes Templiers, 2400 route des Colles
    B.5.3.2Town/ cityBiot
    B.5.3.3Post code06410
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)493-95-70-85
    B.5.5Fax number+33(0)492-95-21-31
    B.5.6E-mailcta.coordinator@galderma.com
    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 Vectical® (calcitriol) ointment 3 mcg/g
    D.2.1.1.2Name of the Marketing Authorisation holderGALDERMA LABORATORIES, L.P.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCalcitriol
    D.3.2Product code D05AX03
    D.3.4Pharmaceutical form Ointment
    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.3.9.4EV Substance CodeSUB06047MIG
    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
    Psoriasis
    Psoriasi
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    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 safety of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 17 years of age) with plaque psoriasis.
    Valutare la sicurezza del trattamento fino a 26 settimane con calcitriolo da 3 mcg/g unguento quando usato due volte al giorno, senza occlusione, per trattare soggetti pediatrici (di età compresa tra i 2 e i 17 anni) affetti da psoriasi a
    placche.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female pediatric subjects (2 to 17 years of age, inclusive) at Screening.

    - The subject has a clinical diagnosis of stable mild to moderate plaque type psoriasis.
    - Soggetti pediatrici di sesso maschile o femminile (da 2 a 17 anni di età inclusi) alla selezione.
    - Il soggetto ha una diagnosi clinica di psoriasi a placche stabile da lieve a moderata.
    E.4Principal exclusion criteria
    - Subjects with guttate psoriasis, pustular psoriasis, erythrodermic psoriasis or active infection (i.e., an infection associated with fever, swollen lymph nodes, and/or signs of localized inflammation of tissue and/or joints).

    - Subject has hypercalcemia (serum albumin-adjusted calcium level above the upper normal range) at Screening.

    - Subjects with known or suspected disorders of calcium metabolism.
    - Soggetti affetti da psoriasi guttata, psoriasi eritrodermica o infezione attiva (ad esempio, un'infezione associata a febbre,
    ingrossamento dei linfonodi e/o segni di infiammazione localizzata del tessuto e/o delle articolazioni).
    - Il soggetto presenta ipercalcemia (livelli sierici del calcio corretti in relazione al livello di albumina superiori al range di normalità)
    alla selezione.
    - Soggetti con disturbi del metabolismo del calcio noti o sospetti.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints:
    - Percentage of subjects with an IGA Score of 0 (clear) or 1 (almost clear).
    - Change from Baseline in Pruritus.
    - Change from Baseline in % BSA.
    Safety endpoints:
    - include Serum albumin-adjusted calcium, urine calcium:creatinine ratio, phosphorus, and PTH.
    Endpoints di efficacia: - Percentuale di soggetti con un punteggio IGA equivalente a 0 (chiaro) o 1 (quasi chiaro). - Variazioni nel prurito rispetto al basale. - Variazioni della %BSA rispetto al basale. Endpoints sulla sicurezza: - Calcio sierico corretto in relazione al livello di albumina, rapporto calcio: creatinina nelle urine, fosforo e PTH.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At each visit
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Germany
    Italy
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 140
    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.1.1.5.1Number of subjects for this age range: 84
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 56
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors are included in the study.
    Persons in this group are not usually able to give the consent, however assent forms will be signed by minors from 6 years and by their parents and/or Guardians.
    Nello studio sono inclusi minori.
    Le persone di questo gruppo di solito non sono in grado di dare il consenso, tuttavia moduli di assenso conformi saranno firmati dai minori.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 140
    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 the study the clinicians will have the prerogative to treat the subject as they would in normal clinical practice
    Alla fine dello studio i medici avranno la prerogativa di trattare il soggetto come farebbero nella 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 Decision2015-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-10
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