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    Summary
    EudraCT Number:2016-002048-18
    Sponsor's Protocol Code Number:16/195
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-002048-18
    A.3Full title of the trial
    Clinical Trial to determine efficacy and safety of healing with platelet-rich
    plasma, fibrin and leukocytes compared to standard healing with
    nitrofurazone ointment in subjects with onychocryptosis.
    Ensayo clínico para determinar eficacia y seguridad de curas con plasma
    rico en plaquetas, fibrina y leucocitos comparado con las curas estándar
    con pomada de nitrofurazona en sujetos con onicocriptosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the effectiveness of the surgery healing the nail between an
    extracted blood product which is rich in platelets , fibrin and leukocytes
    and traditional healing with an antibiotic ointment .
    Comparación de la eficacia de las curas de la cirugia de la uña entre un
    producto extraido de la sangre que es rico en plaquetas, fibrina y
    leucocitos y la cura tradicional con una pomada antibiotica.
    A.3.2Name or abbreviated title of the trial where available
    Clinical Trial to determine efficacy and safety of healing with L-PRF in Onychocryptosis Surgery.
    Ensayo Clínico para determinar la eficacia y seguridad de las curas con LPRF en Onicocriptosis
    A.4.1Sponsor's protocol code number16/195
    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 SponsorUNIVERSIDAD REY JUAN CARLOS
    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 supportUNIVERSIDAD REY JUAN CARLOS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSIDAD REY JUAN CARLOS
    B.5.2Functional name of contact pointXAVIER GARRIDO CASTELLS
    B.5.3 Address:
    B.5.3.1Street AddressSANTS DE LA PEDRA, 91
    B.5.3.2Town/ cityCANALS (VALENCIA)
    B.5.3.3Post code46650
    B.5.3.4CountrySpain
    B.5.4Telephone number34661451622
    B.5.6E-mailxavi3garrido@hotmail.com
    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 FURACIN POMADA
    D.2.1.1.2Name of the Marketing Authorisation holderSEID, S.L.
    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 nameNITROFURAZONE OINTMENT
    D.3.2Product code POMADA
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNITROFURAL
    D.3.9.1CAS number 59-87-0
    D.3.9.2Current sponsor codePOMADA
    D.3.9.3Other descriptive nameFURACIN POMADA
    D.3.9.4EV Substance CodeSUB09325MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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 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 nameLEUCOCYTES, FIBRINE AND PLATELET RICH PLASMA CLOT
    D.3.2Product code COAGULO DE PLASMA
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNL-PRF
    D.3.9.2Current sponsor codeL-PRF
    D.3.9.3Other descriptive namePLASMA
    D.3.9.4EV Substance CodeSUB118891
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Yes
    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 Yes
    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
    THE POST-OPERATIVE OF NAIL SURGERY WITH PHENOL 88% TECHNIQUE IN SUBJECTS WITH ONYCOCRYPTOSIS IN BOTH FIRST TOES HEALINGS WITH NITROFURAZONE OINTMENT OR LEUCOYTES, FIBRINE AND PLATELETS PLASMA CLOT.
    EL POST-OPERATORIO DE LA CIRUGIA UNGUEAL CON TÉCNICA DE FENOL AL 88% EN SUJETOS CON ONICOCRIPTOSIS EN AMBOS PRIMEROS DEDOS DEL PIE CURADOS CON POMADA DE NITROFURAZONA O CON COAGULO DE PLASMA RICO EN PLAQUETAS, LEUCOCITOS Y FIBRINA.
    E.1.1.1Medical condition in easily understood language
    THE PROCES POSTOPERATIVE OF NAIL SURGERY IN PEOPLE WITH INGROWN TOENAILS IN BOTH BIG TOES CURED WITH A ANTIBIOTIC OINMENT OR A PRODUCT OF BLOOD IN FORM OF CLOT.
    EL PROCESO POST-OPERATORIO DE LA CIRUGIA DE LA UÑA ENCARNADA DE LOS DOS DEDOS GORDOS DEL PIE CURADOS CON UNA POMADA ANTIBIÓTICA Y UN PRODUCTO DE LA SANGRE EN FORMA DE COAGULO.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    DETERMINING THE IMPROVEMENT OF POSTOPERATIVE PROCESS WITH HEALING WITH LEUCOCYTES, FIBRINE AND PLATELETS RICH PLASMA CLOT IN COMPARISON WITH THE STANDARD HEALING WITH NITROFURAZONE OINTMENT.
    DETERMINAR LA MEJORA DEL PROCESO POST-OPERATORIO CON LAS CURAS CON COAGULO DE PLASMA RICO EN PLAQUETAS, FIBRINA Y LEUCOCITOS EN COMPARACIÓN CON LA CURA ESTANDAR CON POMADA DE NITROFURAZONA.
    E.2.2Secondary objectives of the trial
    DETERMINING:

    - POSTOPERATIVE HEALING'S DAYS.
    - POSTOPERATIVE HEMORRHAGE.
    - POSTOPERATIVE PAIN.
    - POSTOPERATIVE INFLAMMATION.
    - PRESENCE OF POSTOPERATIVE INFECTION.
    DETERMINAR:

    - Los días de cicatrización de la herida post-quirúrgica.
    - La hemorragia post-operatoria.
    - El dolor post-operatorio.
    - Inflamación post-operatoria.
    - Presencia de infección.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - PEOPLE OVER 18 YEAR.
    - DIAGNOSED OF ONYCOCRYPTOSIS.
    - PERSONAS MAYORES DE 18 AÑOS.

    - DIAGNOSTICADAS DE ONICOCRIPTOSIS.
    E.4Principal exclusion criteria
    PEOPLE:

    - OVER 65 YEARS.

    - WITH DIABETES MELLITUS.

    - WITH OPEN WOUNDS ON THE TOES.

    - WITH ALLERGICS BACKGROUND TO COMPONENTS USED.

    - WITH ATOPIC DERMATITIS OR OTHERS PROBLEMS IN THE SKIN OF TOES.

    - WITHOUT CONTROL OF SYSTEMIC DISEASES.

    - WITH PERIPHERAL VASCULAR DISEASE.

    - WITHOUT MOTOR OR COGNITIVE CAPACITY.

    - WITH ANTICOAGULANT TREATMENT.

    - DISCONFORM WITH INFORMED CONSENTIMENT.
    - Personas mayores de 65 años.
    - Personas con Diabetes Mellitus.
    - Personas con heridas abiertas en los dedos del pie.
    - Personas con antecedentes personales de alergias a cualquiera de los ingredientes de las soluciones empleadas o contraindicación para su uso.
    - Personas con dermatitis atópica o cualquier otra alteración de la piel de los dedos del pie que no garantice su continuidad.
    - Personas con enfermedad sistémica mal controlada o que contraindique la intervención.
    - Personas con enfermedad periférica vascular.
    - Personas con incapacidad cognitiva y/o motora para poder seguir las instrucciones postquirúrgicas.
    - Personas en tratamiento con anticoagulantes.
    - Personas que no acepten ni firmen el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    DECREASE THE DAYS OF TOTAL HEALING OF THE SURGERY NAIL THROUGHT PHENOL 88% TECHNIQUE AROUND 30%.
    DISMINUIR LOS DIAS DE CURACIÓN TOTAL DE LA CIRUGIA UNGUEAL POR LA TÉCNICA DE FENOL AL 88% EN UN 30%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    THE EVALUATION OF THIS POINTS WILL BE 48H POSTOPERATIVE, LATER THE CURES DURING FIVE DAYS CONSECUTIVES, AND LATER EVERY 48H SINCE THE WOUND WILL BE TOTALLY CURED.
    LA EVALUACION DE ESTE PUNTO SERÁ A LAS 48 HORAS POST-OPERATORIAS, DESPUÉS DURANTE 5 DIAS CONSECUTIVOS, Y DESPUES CADA 48 HORAS HASTA LA CURACIÓN TOTAL DE LA HERIDA.
    E.5.2Secondary end point(s)
    1. DECREASE PRESENCE OF HEMORRHAGE POSTOPERAITVE IN 70%.
    2. DECREASE POSTOPERATIVE PAIN IN 70%.
    3. DECREASE POSTOPERATIVE INFLAMATION IN 50%.
    4. DECREASE PRESENCE OF POSTOPERATIVE INFECTIONS IN 80%.
    1. DISMINUIR LA PRESENCIA DE HEMORRAGIA POST-OPERATORIA EN UN 70%.
    2. DISMINUIR EL DOLOR POST-OPERATORIO EN UN 70%.
    3. DISMINUIR LA INFLAMACION POST-OPERATORIA EN UN 50%.
    4. DISMINUIR LA PRESENCIA DE INFECCIÓN EN UN 80%.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. OBSERVED IN FIRST CURE ONLY AT 48H LATER TO SURGERY. DOUBLE BLIND.
    2. EVALUATED WITH A VISUAL ANALOGICAL SCALE PUNTUATION IN THREE FIRST DAYS POST-OPERATIVE.
    3. ONE MEASUREMENT WILL BE TAKE BEFORE SURGERY AND OTHER MEASUREMENT AT 48H POST-OPERATIVE FOR THE SAME INVESTIGATOR.
    4. WILL BE OBSERVED AROUND ALL THE PROCESS OF HEALING.
    1. OBSERVADO EN LA PRIMERA CURA SOLAMENTE A LAS 48 HORAS DESPUES DE LA CIRUGIA. DOBLE CIEGO.
    2. EVALUADO CON UNA PUNTUACIÓN EN UNA ESCALA ANALOGICA VISUAL DEL DOLOR DURANTE LOS TRES PRIMEROS DIAS POSTQUIRÚRGICOS.
    3. UNA MEDIDA SE TOMARA ANTES DE LA CIRUGIA Y OTRA A LAS 48 HORAS DESPUES DE LA MISMA.
    4. SERA OBSERVADO DURANTE TODO EL PROCESO DE CURACIÓN.
    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 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) Yes
    E.8.2.2Placebo No
    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
    The end of the trial is make a improvement in the post-operative process of nail surgery through phenol 88% technique.
    This technique of surgery have a hight points of effectiveness, but it exist a retardation healing process of surgery wound.
    With the use of leucocytes, fibrine and platelets rich plasma clot, we want take a solution a this problem and dcrease the number of complications like the infections rate and recurrences.
    El fin del estudio es mejorar el proceso post-operatorio de la cirugía ungueal mediante técnica de fenol al 88%. Dicha técnica tiene una alta efectividad pero existe una cicatrización retardada de la herida quirúrgica. Mediante la utilización del coagulo de plasma rico en plaquetas, leucocitos y fibrina, en las curas, pretendemos dar solución a esta problemática y reducir el número de complicaciones como la tasa de infecciones y recidivas.
    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: 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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. This trial is finish when it exist a totally healing wound.
    No. Este etudio termina cuando la herida esta completamente cicatrizada.
    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 Decision2016-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-23
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