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    Summary
    EudraCT Number:2014-003218-98
    Sponsor's Protocol Code Number:LP0041-1120
    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:2015-03-11
    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 number2014-003218-98
    A.3Full title of the trial
    Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.
    Eficacia y seguridad de mebutato de ingenol en gel al 0,015 % en comparación con diclofenaco sódico en gel al 3 % en pacientes con queratosis actínicas en la cara o el cuero cabelludo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.
    Eficacia y seguridad de mebutato de ingenol en gel al 0,015 % en comparación con diclofenaco sódico en gel al 3 % en pacientes con queratosis actínicas en la cara o el cuero cabelludo.
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberLP0041-1120
    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 SponsorLEO Pharma A/S
    B.1.3.4CountryDenmark
    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 supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInVentivhealth
    B.5.2Functional name of contact pointInVentivhealth
    B.5.3 Address:
    B.5.3.1Street AddressPau Claris 196 5º
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932555603
    B.5.5Fax number+34932555640
    B.5.6E-mailclaudia.miranda@leo-pharma.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 Picato 150 micrograms/gram gel
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Gel
    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.3.8INN - Proposed INNingenol mebutate
    D.3.9.1CAS number 75567-37-2
    D.3.9.3Other descriptive name3-Angeloyl ingenol, Ingenol-3-angelate, 3-O-angeloylingenol
    D.3.9.4EV Substance CodeSUB32495
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Solaraze 3% gel
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    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.3.4Pharmaceutical form Gel
    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.3.8INN - Proposed INNDiclofenac sodium
    D.3.9.1CAS number 15307-79-6
    D.3.9.4EV Substance CodeSUB01674MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Actinic keratosis on the face or scalp
    queratosis actínicas en la cara o el cuero cabelludo
    E.1.1.1Medical condition in easily understood language
    Actinic keratosis on the face or scalp
    queratosis actínicas en la cara o el cuero cabelludo
    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 PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of daily application for 3 consecutive days of ingenol mebutate gel 0.015% with the efficacy of diclofenac sodium gel 3% for 90 days in subjects with AK on the face or scalp.
    Comparar la eficacia de la aplicación diaria durante 3 días consecutivos de mebutato de ingenol en gel al 0,015% con la eficacia de diclofenaco sódico en gel al 3 % durante 90 días en pacientes con queratosis actínica (QA) en la cara o el cuero cabelludo.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of up to two treatment courses of ingenol mebutate gel 0.015% (daily application for 3 consecutive days) with the efficacy of diclofenac sodium gel 3% for 90 days in subjects with AK on the face or scalp.
    Comparar la eficacia de un máximo de dos ciclos de tratamiento con mebutato de ingenol en gel al 0,015% (aplicación diaria durante 3 días consecutivos) con la eficacia de diclofenaco sódico en gel al 3 % durante 90 días en pacientes con QA en la cara o el cuero cabelludo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Following verbal and written information about the trial, the subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
    2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp
    1. Tras la información oral y escrita del ensayo, el paciente debe proporcionar el consentimiento informado, documentado mediante la firma del formulario de consentimiento informado (FCI) antes de realizar cualquier procedimiento relacionado con el ensayo.
    2. Pacientes que presenten entre 4 y 8 QA aisladas, visibles y clásicas desde el punto de vista clínico, en una zona de tratamiento de 25 cm² contiguos en la cara o el cuello cabelludo.
    E.4Principal exclusion criteria
    1. Location of the selected treatment area:
    ? on the periorbital skin
    ? on the perioral skin/around the nostrils
    ? within 5 cm of an incompletely healed wound
    ? within 10 cm of a suspected BCC or SCC or other neoplasia
    2. Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn) or recalcitrant disease (e.g., did not respond to AK treatment in the previous)
    3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatmentarea
    4. History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
    5. Use of ingenol mebutate and/or diclofenac sodium in and within 5 cm of the selected treatment area within the last 12 months prior to Visit 1
    6. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment area
    7. Known or suspected hypersensitivity or allergy to any of the ingredients in ingenol mebutate gel or diclofenac sodium gel
    8. Organ transplant recipients
    9. Immunosuppressed subjects (for example HIV patients)
    10. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator?s clinical judgment
    11. Presence of acute sunburn within the selected treatment area
    12. Current enrolment or participation in a clinical trial within 30 days of entry into this
    trial
    13. Subjects previously randomised in the trial
    14. Female subjects who are breastfeeding
    15. Subjects who are institutionalized by court order or by the local authority
    16. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
    1. Ubicación de la zona de tratamiento seleccionada:
    • en la piel periorbitaria
    • en la piel peribucal/alrededor de los orificios nasales
    • en los 5 cm alrededor de una herida que no se haya curado por completo
    • en los 10 cm alrededor de un presunto carcinoma de células basales (CCB) o carcinoma de células escamosas (CCE) u otra neoplasia.
    2. Lesiones en el área de tratamiento seleccionada que tengan un aspecto clínico atípico (p.e. hipertróficas, hiperqueratósicas o cuerno cutáneo) o enfermedades recalcitrantes (p.e. no respuesta a tratamiento previo de QA)
    3. Historia de SCC, BCC, melanoma maligno u otra neoplasia en el área de tratamiento seleccionada.
    4. Historia o evidencia de problemas cutáneos que no sean los de la indicación del ensayo, los cuales interfieran en la evaluación de la medicación en el ensayo en el área de tratamiento seleccionada (p.e. eczema, psoriasis inestable, xeroderma pigmentosum).
    5.Uso de ingenol mebutato y/o diclofenaco sódico en el área de tratamiento seleccionada y dentro de 5 cm del área de tratamiento seleccionada, dentro de los últimos 12 meses anteriores a la visita1.
    6. Uso de cosméticos o productos terapéuticos y procedimientos, los cuales puedan interferir con las valoraciones del área de tratamiento.
    7. Hipersensibilidad conocida o sospechada de alergia a cualquiera de los componentes de ingenol mebutato gel o diclofenaco sódico gel.
    8. Receptores de órganos transplantados
    9. Sujetos inmunodeprimidos (por ejemplo pacientes con HIV)
    10. Diagnostico clínico/historia o evidencia de alguna afección médica que pueda exponer al sujeto a un riesgo innecesario o a un AA significativo o interferir con valoraciones de seguridad y eficacia durante el curso del ensayo, tal y como esté determinado por el criterio del investigador.
    11. Presencia de quemaduras solares agudas en el área de tratamiento selecionada
    12. Reclutamiento actual o participación en un ensayo clínico dentro de los 30 días de entrar en éste ensayo.
    13. Sujetos previamente randomizados en el ensayo
    14. Sujetos femeninos que estén lactando
    15. Sujetos que estén encarcelados por orden judicial o por la autoridad local
    16. En opinión del investigador, un sujeto que a duras penas pueda cumplir con el protocolo del ensayo (p.e. alcoholismo, drogodependientes o estados psicóticos)
    E.5 End points
    E.5.1Primary end point(s)
    Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3%
    Remisión completa de todas las QA en la zona de tratamiento en la semana 8 con mebutato de ingenol en gel al 0,015 % y en la semana 17 con diclofenaco sódico en gel al 3 %.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation at week 8 for ingenol mebutate gel 0.015%.
    Evaluation at week 17 for diclofenac sodium gel 3%.
    Evaluación en la semana 8 para ingenol mebutato gel 0.015%
    Evaluación en semana 17 para diclofenaco sódico gel 3%
    E.5.2Secondary end point(s)
    As secondary response criteria, complete clearance at Week 17 for diclofenac sodium gel 3% will be compared with the following three measures of complete clearance in the ingenol mebutate 0.015% group:
    - Complete clearance of all AKs in the treatment field after one or two ingenol mebutate treatment courses. Subjects receiving only one treatment course are evaluated at Week 8 and subjects receiving two treatment courses are evaluated at Week 17.
    - Complete clearance of all AKs in the treatment field at Week 17
    - Complete clearance of all AKs in the treatment field at Week 17 following only one ingenol mebutate treatment course. Subjects receiving a second ingenol mebutate treatment course are considered non-cleared.
    Como criterios de respuesta secundarios, se comparará la remisión completa en la semana 17 con diclofenaco sódico en gel al 3 % con las tres medidas siguientes de remisión completa en el grupo de mebutato de ingenol al 0,015 %:
    • Remisión completa de todas las QA en la zona de tratamiento tras uno o dos ciclos de tratamiento con mebutato de ingenol. Los pacientes que solo reciben un ciclo de tratamiento se evalúan en la semana 8 y los pacientes que reciben dos ciclos de tratamiento se evalúan en la semana 17.
    • Remisión completa de todas las QA en la zona de tratamiento en la semana 17
    • Remisión completa de todas las QA en la zona de tratamiento en la semana 17 tras un solo ciclo de tratamiento con mebutato de ingenol. Los pacientes que reciben un segundo ciclo de tratamiento con mebutato de ingenol, se considera que no presentan remisión de las lesiones.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation at week 17 for diclofenac sodium gel 3% (all secondary endpoints).
    For ingenol mebutate gel 0.015%:
    1st secondary endpoint: Evaluation at week 8 for subjects receiving one treatment course, evaluation at week 17 for subjects receiving two treatment courses.
    2nd secondary endpoint: Evaluation at week 17.
    3rd secondary endpoint: Evaluation at week 17 for subjects receiving one treatment course, evaluation at week 8 for subjects receiving two treatment courses.
    Evaluación en la semana 17 para diclofenaco sódico gel 3% (todos los objetivos secundarios).
    Para ingenol mebutato gel 0.015%:
    1º objetivo secundario: Evaluación en semana 8 para sujetos que reciben un tratamiento, evaluación en la semana 17 para sujetos que reciben dos tratamientos.
    2º objetivo secundario: Evaluación en la semana 17
    3º objetivo secundario: Evaluación en semana 17 para sujetos que reciben mas de un tratamiento, evaluación en la semana 8 para sujetos que reciben dos tratamientos.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 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.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Solaraze 3% gel
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    última visita del último sujeto
    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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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)
    After the completion of the trial, the subjects will be treated at the investigator's discretion or referred to other physician(s) according to standard practice.
    Tras la finalización del ensayo, los sujetos serán tratados a criterio del investigador o derivados a otro(s) médico(s) de acuerdo con la práctica habitual.
    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 Decision2015-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-10
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