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    Summary
    EudraCT Number:2019-002285-12
    Sponsor's Protocol Code Number:OJ-KDC01
    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:2019-10-21
    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 number2019-002285-12
    A.3Full title of the trial
    An exploratory, multicenter, randomized, open-label with blind evaluation, active-controlled study to evaluate the safety and efficacy of Keramod
    (imiquimod 50 mg/g, Gel) compared with Aldara (imiquimod 50 mg/g, Cream) for the treatment of actinic keratosis in adults
    Estudio exploratorio, aleatorizado, abierto con evaluación ciega, multicéntrico, controlado con control activo, para evaluar la eficacia y seguridad de la aplicación tópica de KERAMOD (gel de imiquimod 50 mg/g) frente Aldara (crema de imiquimod 50 mg/g) en el tratamiento de queratosis actínica (QA) en adultos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Keramod Gel vs Aldara for the treatment of actinic keratosis
    Keramod Gel vs Aldara en el tratamiento de la queratosis actínica
    A.4.1Sponsor's protocol code numberOJ-KDC01
    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 SponsorLABORATORIO OJER PHARMA, S.L.
    B.1.3.4CountrySpain
    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 supportLABORATORIO OJER PHARMA, S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLABORATORIO OJER PHARMA, S.L.
    B.5.2Functional name of contact pointPATRICIA OJER
    B.5.3 Address:
    B.5.3.1Street AddressCALLE SANCHO EL MAYOR, Nº2 1ºIZQ
    B.5.3.2Town/ cityPAMPLONA
    B.5.3.3Post code31002
    B.5.3.4CountrySpain
    B.5.4Telephone number34948281776
    B.5.5Fax number34948287859
    B.5.6E-mailpojer@ojerpharma.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 nameKERAMOD
    D.3.2Product code NA
    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 INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.2Current sponsor codeIMIQUIMOD
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 ALDARA
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB
    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 Cream
    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 INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.2Current sponsor codeIMIQUIMOD
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 QUERATOSIS, also known as solar keratosis, is a skin disease caused by chronic exposure to sunlight. It appears as scaly lesions on the skin as a result of an abnormal growth of the cells in the most outer layer of the epidermis. There may be a single lesion or multiple lesions, and they are usually found on areas of the skin that are regularly exposed to the sun, such as the face, neck, hands, forearms and scalp.
    QUERATOSIS ACTÍNICA, Conocida también como queratosis solar, La queratosis actínica es un parche grueso y escamoso en la piel, que se desarrolla después de muchos años de exposición al sol. Comúnmente se encuentra en el rostro, cuello, el dorso de las manos, los antebrazos y el cuero cabelludo.
    E.1.1.1Medical condition in easily understood language
    ACTINIC QUERATOSIS, also known as solar keratosis, is a skin disease caused by chronic exposure to sunlight.
    QUERATOSIS ACTÍNICA, Conocida también como queratosis solar, La queratosis actínica es un parche grueso y escamoso en la piel, que se desarrolla después de muchos años de exposición al sol.
    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
    To evaluate the efficacy of Keramod® Gel (imiquimod 5%, Gel) versus Aldara® Cream (imiquimod 5%, cream), in the treatment of AK in terms of complete clearance of AK lesions at week 24 since the first treatment dose.
    Evaluar la eficacia de Keramod® Gel (imiquimod al 5 %, gel) frente a Aldara® Crema (imiquimod al 5 %, crema) en el tratamiento de la queratosis actínica (QA) en términos de eliminación completa de las lesiones de la QA 24 semanas después de la primera dosis del tratamiento
    E.2.2Secondary objectives of the trial
    • To evaluate the reduction in the number of AK lesions from baseline to weeks 8 and 16 in subjects treated with Keramod® Gel versus Aldara® Cream.
    • To evaluate the efficacy of Keramod® Gel (imiquimod 5%, Gel) versus Aldara® Cream (imiquimod 5%, cream).
    • To evaluate the safety of the topical treatment of Keramod® Gel versus Aldara® Cream.
    • To evaluate the treatment tolerance and patient acceptance of the treatment in subjects treated with Keramod® Gel versus Aldara® Cream.
    • To evaluate quality of life in subjects treated with Keramod® Gelm versus Aldara® Cream.
    - Evaluar la redución de lesiones desde la visita la visita basal hasta la semana 8 y semana 16 de tratamiento en pacientes tratados con Keramod Gel frente a Aldara
    - Evaluar la eficacia de Keramod Gel frente Aldara en función de las lesiones eliminadas en la semana 8 y la semana 16
    - Evaluar la seguridad del tratamiento con Keramod Gel frente a Aldara
    - Evaluar la tolarancia y aceptación del tratamiento con Keramod Gel frente a Aldara
    - Evaluar la Calidad de Vida en los pacientes tratados con Keramod frente a los tratados con Aldara
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp.
    Presencia de entre 4 y 8 lesiones de QA diagnosticadas clínicamente, no hiperqueratósicas y no hipertróficas, en una zona de tratamiento contigua de 25 cm2 en el cuero cabelludo parcialmente sin pelo o en la cara.
    E.4Principal exclusion criteria
    Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp), in the treatment area.
    Presencia, en la zona de tratamiento (cara o cuero cabelludo), de carcinoma de células basales o escamosas u otros trastornos cutáneos que puedan inducir a confusión.
    E.5 End points
    E.5.1Primary end point(s)
    Complete clearance of AK lesions, defined as a count of zero AK lesions at week 24 since the first treatment dose.
    Eliminación completa de las lesiones de la AQ, lo que se define como un recuento cero de lesiones de QA en la semana 24, a contar desde la primera dosis del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: 8 weeks post-treatment (Week 24, Test of Cure/ TOC, visit 6)
    Período de tiempo: 8 semanas después del tratamiento (semana 24, Test of Cure (TOC), visita 6)
    E.5.2Secondary end point(s)
    • Partial clearance rate of AK lesions at the end of first treatment cycle: proportion of subjects with at least a 75% reduction in the number of AK lesions counted at baseline.
    • Complete clearance rate of AK lesions at the end of first treatment cycle: proportion of subjects with a count of zero AK lesions
    • Tolerance and acceptability of the treatment by the study subject assessed by the Treatment tolerance and satisfaction questionnaire
    • Quality of life assessed by the Actinic Keratosis Quality of Life Questionnaire
    • Rate of subjects who complete one treatment cycle
    • Severity and frequency of associated adverse events/serious adverse events (AEs/SAEs)
    - Eliminación parcial de las lesiones de QA
    - Eliminación Completa de las lesiones de QA
    - Tolerancia y Aceptación del tratamiento
    - Evaluación de la Calidad de Vida
    - Ratio de pacientes que completan 1 ciclo de tratamiento
    - Ratio de pacientes que completan 2 ciclos de tratamiento
    - Gravedad y Frecuencia de los AEs/SAEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Partial and Complete clearance rate of AK lesions at the end of first and second cycles.: Week 8 (end of first cycle treatment period; visit 3) and Week 16 (end of second cycle treatment period; visit 5).
    • Tolerance and acceptability: Visits 2, 3, 4, 5 & 6.
    • Quality of life assessed: Week 24; Visit 6.
    • Rate of subjects who complete one and two treatment cycles: Week 8; Visit 3 and Week 16; Visit 5.
    • Severity and frequency of associated adverse events/serious adverse events: Week 24.
    - Eliminación parcial de las lesiones de QA: Semana 8 (Visita 3) y Semana 16 (Visita 5)
    - Eliminación Completa de las lesiones de QA: Semana 8 (Visita 3) y Semana 16 (Visita 5)
    - Tolerancia y Aceptación del tratamiento: Visitas 2, 3, 4, 5 & 6
    - Evaluación de la Calidad de Vida: Semana 24 (Visita 6)
    - Ratio de pacientes que completan 1 ciclo de tratamiento: Semana 8 (Visita 3)
    - Ratio de pacientes que completan 2 ciclos de tratamiento: Semana 16 (Visita 5)
    - Gravedad y Frecuencia de los AEs/SAEs: Week 24
    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 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 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
    ALDARA
    ALDARA
    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 concerned2
    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
    End of Study (Visit 6): All subjects will attend to a post-treatment visit that will be in 8 weeks after the last administration of the study treatment (Visit 6, day 169).
    The procedures scheduled for this visit may be carried out within 4 days of the scheduled visit (i.e. Day 169 ± 4 days).
    Fin de estudio (Visita 6): Todos los pacientes asistirán a esta visita planeada 8 semanas después de la última dosis. (Visita 6, dia 169).
    Los procedimientos de esta visita se pueden realizar con una ventana de 4 dias (Dia 169 +/- 4 días).
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state68
    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
    Ninguno
    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 Decision2019-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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