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   43874   clinical trials with a EudraCT protocol, of which   7294   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:2022-003913-12
    Sponsor's Protocol Code Number:22/589-EC_M.
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-003913-12
    A.3Full title of the trial
    Diode laser and photodynamic therapy Versus Ciclopirox Hydroxypropyl Chitosan. Randomised controlled clinical trial.
    Láser diodo y terapia fotodinámica Versus Ciclopirox Hidroxipropil Quitosano. Ensayo clínico controlado y aleatorizado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Laser and photodynamic therapy versus Ciclopirox nail varnish. Clinical trial.
    Láser y terapia fotodinámica Versus Ciclopirox laca de uñas. Ensayo clínico.
    A.4.1Sponsor's protocol code number22/589-EC_M.
    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 SponsorCOMPLUTENSE UNIVERSITY OF MADRID
    B.1.3.4CountrySpain
    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 supportCOMPLUTENSE UNIVERSITY OF MADRID
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNA
    B.5.2Functional name of contact pointNA
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountrySpain
    B.5.4Telephone number+34919611502
    B.5.5Fax numberNA913941535
    B.5.6E-mailalvaro@ucm.es
    D. IMP Identification
    D.IMP: 1
    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 Ciclopirox 8% (Onytec)
    D.2.1.1.2Name of the Marketing Authorisation holderAEMPS
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLASER DIODO
    D.3.4Pharmaceutical form Transdermal system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiclopirox
    D.3.9.3Other descriptive nameLaca de uñas
    D.3.9.4EV Substance CodeSUB06245MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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) Yes
    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
    Onychomycosis
    Onicomicosis.
    E.1.1.1Medical condition in easily understood language
    Nail fungus.
    Hongos en las uñas.
    E.1.1.2Therapeutic area Not possible to specify
    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 main objective of this study is to compare the efficacy of treatment of onychomycosis by: diode laser combined with photodynamic therapy, and topical treatment with Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
    El objetivo principal de este estudio es comparar la eficacia del tratamiento de la onicomicosis mediante: láser diodo combinado con terapia fotodinámica, y el tratamiento tópico con Ciclopirox Hidroxipropil Quitosano (HPCH) Laca de Uñas.
    E.2.2Secondary objectives of the trial
    Secondary objectives have been defined as follows:

    - To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve clinical, mycological and complete cure of onychomycosis.
    - To analyse the influence of the type of onychomycosis (ODL, total dystrophic, superficial), the causal fungal agent (dermatophyte, mould or yeast) and the degree of severity of onychomycosis (via OSI) on the response to treatment.
    Como objetivos secundarios se han definido:

    • Determinar si 8 sesiones de tratamiento láser diodo combinado con terapia fotodinámica, a distintas longitudes de onda, en un período de nueve semanas, es suficiente para conseguir la cura clínica, micológica y completa de la onicomicosis.
    • Analizar la influencia del tipo de onicomicosis (ODL, distrófica total, superficial), el agente fúngico causal (dermatofito, moho o levadora) y el grado de severidad de la onicomicosis (a través del OSI) en la respuesta al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients diagnosed with toenail onychomycosis with positive microbiological culture/PCR.
    - Patients over 18 years of age.
    • Pacientes diagnosticados de onicomicosis en las uñas de los pies con cultivo microbiológico/PCR positivo.
    • Pacientes mayores de 18 años.
    E.4Principal exclusion criteria
    - Patients who have received topical or systemic antifungal treatment in the previous month.
    - Pregnancy or lactation.
    - Patients with peripheral vascular disease.
    - Patients with an immune system disorder or undergoing treatment with immunosuppressants.
    - Patients with peripheral or central neuropathy.
    - Patients with a coagulation disorder.
    - Patients with Raynaud's disease or with any alteration in the perception of cold or heat.
    • Pacientes que hayan recibido tratamiento antifúngico tópico o sistémico en el mes anterior.
    • Embarazo o lactancia.
    • Pacientes con enfermedad vascular periférica.
    • Pacientes con un trastorno del sistema inmunitario o en tratamiento con inmunosupresores.
    • Pacientes con algún tipo de neuropatía periférica o central.
    • Pacientes que presenten algún trastorno de la coagulación.
    • Pacientes con enfermedad de Raynaud o con alguna alteración de la percepción del frío o calor.
    E.5 End points
    E.5.1Primary end point(s)
    Main variables:

    - Clinical healing (outcome variable): yes/no.

    Clinical improvement was any visual improvement of the nail as assessed by the investigator at clinical examination.
    - Mycological healing (outcome variable): yes/no.

    Mycological healing was defined as at least one negative mycological laboratory test.
    - Complete healing (outcome variable): yes/no.

    Complete cure was clinically normal nail with a negative mycological examination.
    - Treatment group:
    o Diode laser treatment combined with photodynamic therapy.
    o Treatment with Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
    Variables principales:

    • Curación clínica (variable resultado): si/no.

    La mejora clínica fue cualquier mejora visual de la uña evaluada por el investigador en el examen clínico.
    • Curación micológica (variable resultado): si/no.

    La curación micológica se definió como al menos una prueba de laboratorio micológica negativa.
    • Curación completa (variable resultado): si/no.

    La curación completa fue la uña clínicamente normal con un examen micológico negativo.
    • Grupo de tratamiento:
    o Tratamiento con láser diodo combinado con terapia fotodinámica.
    o Tratamiento con Ciclopirox Hidroxipropil Quitosano (HPCH) Laca de Uñas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits will be made every 7 days for a period of 9 weeks in group 1 and monthly in group 2, and reviews at 3, 6, 9 and 12 in both groups, where data will be recorded for the primary and secondary study variables.
    Regardless of the follow-up week at which cure occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.
    Se realizarán visitas cada 7 días durante un período de 9 semanas en el grupo 1 y mensualmente en el grupo 2, y revisiones a los 3, 6, 9 y 12 en los dos grupos, en las que se registrarán los datos correspondientes a las variables principales y secundarias del estudio.
    Independientemente de la semana de seguimiento en la que se produzca la curación, se realizará una revisión de todos los pacientes a los 3, 6, 9 y 12 meses después de la primera visita.
    E.5.2Secondary end point(s)
    - History of onychomycosis: yes/no.
    - Number of affected nails.
    - Location: hallux, second toe, third toe, fourth toe, fifth toe.
    - Evolution (months): time since the onset of signs and symptoms of onychomycosis.
    - Previous treatment: yes/no. Where appropriate, the type of treatment should be indicated.
    - Type of fungus: dermatophyte, mould, yeast.
    - Type of onychomycosis: superficial onychomycosis, distal lateral onychomycosis, total dystrophic onychomycosis.
    - Degree of severity of onychomycosis as measured by OSI at baseline, 3, 6, 9 and 12 months.
    - Relapse of onychomycosis during 12 months follow-up: yes/no.
    • Antecedentes de onicomicosis: sí/no.
    • Número de uñas afectadas.
    • Localización: hallux, segundo dedo, tercer dedo, cuarto dedo, quinto dedo.
    • Evolución (meses): tiempo desde la aparición de signos y síntomas de onicomicosis.
    • Tratamiento previo: sí/no. En su caso se indicará el tipo de tratamiento.
    • Tipo de hongo: dermatofito, moho, levadura.
    • Tipo de onicomicosis: onicomicosis superficial, onicomicosis distal lateral, onicomicosis distrófica total.
    • Grado de severidad onicomicosis a través del OSI al inicio del estudio, a los 3, 6, 9 y 12 meses.
    • Recidiva de onicomicosis durante los 12 meses de seguimiento: sí/no.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits will be made every 7 days for a period of 9 weeks in group 1 and monthly in group 2, and reviews at 3, 6, 9 and 12 in both groups, where data will be recorded for the primary and secondary study variables.
    Regardless of the follow-up week at which cure occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.
    Se realizarán visitas cada 7 días durante un período de 9 semanas en el grupo 1 y mensualmente en el grupo 2, y revisiones a los 3, 6, 9 y 12 en los dos grupos, en las que se registrarán los datos correspondientes a las variables principales y secundarias del estudio.
    Independientemente de la semana de seguimiento en la que se produzca la curación, se realizará una revisión de todos los pacientes a los 3, 6, 9 y 12 meses después de la primera visita.
    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.8.1.7.1Other trial design description
    NA
    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
    CICLOPIROX 8%
    CICLOPIROX 8%
    E.8.2.4Number of treatment arms in the trial8
    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
    NA
    NA
    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: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1
    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)
    NA
    NA
    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 Decision2023-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-22
    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-Thu May 16 06:57:17 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA