Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44132   clinical trials with a EudraCT protocol, of which   7324   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-004962-76
    Sponsor's Protocol Code Number:Solenne-OxoF-Rosa
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-02
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004962-76
    A.3Full title of the trial
    The treatment of Rosacea with Oxofulleram. A pilot study to assess the clinical applicability of Oxofulleram
    De behandeling van Rosacea met Oxofulleram. Een pilotonderzoek naar de klinische toepasbaarheid van Oxofulleram
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The treatment of Rosacea with Oxofulleram. A pilot study to assess the clinical applicability of Oxofulleram
    De behandeling van Rosacea met Oxofulleram. Een pilotonderzoek naar de klinische toepasbaarheid van Oxofulleram
    A.3.2Name or abbreviated title of the trial where available
    The treatment of Rosacea with Oxofulleram
    De behandeling van Rosacea with Oxofulleram
    A.4.1Sponsor's protocol code numberSolenne-OxoF-Rosa
    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 SponsorSolenne BV
    B.1.3.4CountryNetherlands
    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 supportSolenne BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSolenne BV
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressZernikepark 8
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9747 AN
    B.5.3.4CountryNetherlands
    B.5.6E-mailinfo@solennebv.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 No
    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 nameOxofulleram
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous liquid
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    papulopustular rosacea
    papulopustuleuze rosacea
    E.1.1.1Medical condition in easily understood language
    rosacea
    rosacea
    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
    The primary objective of the study is to investigate whether there is an objective established left-right difference detectable in patients with papulopustular rosacea when Oxofulleram is applied twice a day topically unilaterally in the face.
    Het primaire doel van de studie is om te onderzoeken of er een objectief vastgesteld links-rechts verschil aantoonbaar is bij patiënten met een papulopustuleuze rosacea, wanneer Oxofulleram twee keer per dag topicaal unilateraal in het gelaat wordt toegepast.
    E.2.2Secondary objectives of the trial
    Are then any side effects detectable when in patients with papulopustular rosacea when Oxofulleram is applied twice a day topically unilaterally in the face.
    Het secundaire doel van de studie is om te onderzoeken of er bijwerkingen ontstaan bij patiënten met papulopustuleuze rosacea, wanneer Oxofulleram twee keer per dag topicaal unilateraal in het gelaat wordt toegepast.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - a diagnosis of papulopustular rosacea;
    - the conventional treatments of rosacea should be stopped with a wash-out period of one month;
    - age 18-65 years;
    - male and female;
    - women of childbearing age use double barrier contraception
    - Een gestelde diagnose van papulopustuleuze rosacea;
    - Er dient gestopt te worden met de conventionele behandelingen van rosacea met een uitwasperiode van een maand;
    - leeftijd 18-65 jaar;
    - man en vrouw;
    - vrouwen in vruchtbare leeftijd gebruiken dubbele anticonceptie
    E.4Principal exclusion criteria
    - Patients with non papulopustular subtypes of rosacea are excluded from the study;
    - Patients with other facial dermatoses (acne, perioral dermatitis, eczema);
    - Age: younger than 18 and older than 65 years;
    - Pregnancy;
    - Patients treated with an EGFR inhibitor for an oncological condition are excluded from the study;
    - Legally incapable.
    Patiënten met de niet papulopustuleuze subtypes van rosacea worden uitgesloten van de studie;
    - Patiënten met andere faciale dermatosen (acne, periorale dermatitis, eczeem);
    - Leeftijd: jonger dan 18 en ouder dan 65 jaar;
    - Zwangerschap;
    - Patiënten die behandeld worden met een EGFR inhibitor voor een oncologische aandoening worden geëxcludeerd van de studie;
    - Wilsonbekwaamheid
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    The difference of the Rosacea Clinical Score on the treated and placebo-treated face halves;
    The difference of the Patient Self-evaluation on the treated and placebo-treated face halves.
    Primaire eindpunt:
    Het verschil van de Rosacea Klinische Score op de behandelde en met placebo-behandelde gezichtshelften;
    Het verschil van de Patiënt Zelfevaluatie tussen de twee gezichtshelften.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint:
    The difference of the Rosacea Clinical Score on the treated and placebo-treated face halves at week 2, 4, 6, 8, 10 en 12;
    The difference of the Patient Self-evaluation on the treated and placebo-treated face halves at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 en 12.
    Primaire eindpunt:
    Het verschil van de Rosacea Klinische Score op de behandelde en met placebo-behandelde gezichtshelften op week 2, 4, 6, 8, 10 en 12;
    Het verschil van de Patiënt Zelfevaluatie tussen de twee gezichtshelften op week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 en 12.
    E.5.2Secondary end point(s)
    Side effects
    Bijwerkingen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Side effects at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12.
    Bijwerkingen op week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 en 12.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    blinded observer studie omdat "blinde" patienten niet kunnen worden gegarandeerd
    blinded observer study due to the fact the a blinded patient cannot be quaranteed
    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 trial1
    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
    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 months6
    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: 20
    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 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 state20
    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
    Niet van toepassing
    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 Decision2014-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-27
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA