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    Summary
    EudraCT Number:2021-006474-23
    Sponsor's Protocol Code Number:BTIIMD-01-EC/21/LIQUEN
    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:2021-12-23
    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 number2021-006474-23
    A.3Full title of the trial
    Randomized, treatment-controlled clinical trial Conventional efficacy of Plasma Rich in Factors of Growth (PRGF®) in the treatment of atrophic vulvar lichen sclerosus
    Ensayo clínico, aleatorizado, controlado con tratamiento convencional de eficacia del Plasma Rico en Factores de
    Crecimiento (PRGF®) en el tratamiento del liquen escleroso atrófico vulvar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the efficacy of Plasma Rich in Growth Factors (PRGF®) in the treatment of vulvar lichen sclerosus atrophicus
    Ensayo clínico para valorar la eficacia del Plasma Rico en Factores de Crecimiento (PRGF®) en el tratamiento del liquen escleroso atrófico vulvar
    A.4.1Sponsor's protocol code numberBTIIMD-01-EC/21/LIQUEN
    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 SponsorBTI I MAS D S.L.
    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 supportBTI I MAS D
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBTI I MAS D
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressJacinto Quincoces 39
    B.5.3.2Town/ cityVitoria
    B.5.3.3Post code01007
    B.5.3.4CountrySpain
    B.5.6E-mailmikel.allende@bti-implant.es
    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 namePRGF
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRGF
    D.3.9.3Other descriptive namePLATELET CONCENTRATE
    D.3.9.4EV Substance CodeSUB14918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    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.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 Clovate
    D.2.1.1.2Name of the Marketing Authorisation holderIndustrial Farmacéutica Cantabria 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.3.1Product nameClovate
    D.3.4Pharmaceutical form Cutaneous emulsion
    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 INNCLOBETASOL PROPIONATE
    D.3.9.1CAS number 25122-46-7
    D.3.9.3Other descriptive nameClovate
    D.3.9.4EV Substance CodeSUB01346MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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: 3
    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 namePRGF
    D.3.4Pharmaceutical form Concentrate for cutaneous solution
    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 INNPRGF
    D.3.9.3Other descriptive namePLATELET CONCENTRATE
    D.3.9.4EV Substance CodeSUB14918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for dip emulsion
    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
    Vulvar Lichen Sclerosus et atrophicus
    Lichen escleroso atrófico vulvar
    E.1.1.1Medical condition in easily understood language
    Vulvar Lichen
    Liquen vulvar
    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
    Analyze the efficacy of PRGF® in the evolution of quality of life of patients with vulvar lichen sclerosus et atrophicus at six and
    eight months.
    Analizar la eficacia del PRGF® en la evolución de la calidad de vida de pacientes con liquen escleroso atrófico vulvar (LEA) a los seis y ocho meses.
    E.2.2Secondary objectives of the trial
    1. Study the evolution of dermatological quality of life at 1 and 3 months.
    2. Study the clinical evolution at 1, 3, 6 and 8 months.
    3. Study the evolution of pain at 1, 3, 6 and 8 months.
    4. Study the global impression of improvement at 1, 3, 6 and 8 months.
    5. Characterization of blood hematological parameters and PRGF®.
    6. Frequency of recurrences at 6 and 8 months of treatment.
    7. Evaluate the safety of PRGF®.
    1. Estudiar la evolución de calidad de vida dermatológica a los 1 y 3 meses.
    2. Estudiar la evolución clínica a los 1, 3, 6 y 8 meses.
    3. Estudiar la evolución del dolor a los 1, 3, 6 y 8 meses.
    4. Estudiar la impresión global de mejora a los 1, 3, 6 y 8 meses.
    5. Caracterización de los parámetros hematológicos sanguíneos y de PRGF®.
    6. Frecuencia de recidivas a los 6 y 8 meses de tratamiento.
    7. Evaluar la seguridad del PRGF®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age> 18 years
    - Woman with symptoms associated with LEA confirmed with histological study
    - Spend 1 month without previous treatment in the affected area as a washing period
    - Availability of observation during the treatment period
    - Signature of the informed consent
    - Edad >18 años
    - Mujer con sintomatología asociada a LEA confirmado con estudio histológico
    - Estar 1 mes sin tratamiento previo en la zona afectada como periodo de lavado
    - Disponibilidad de observación durante el periodo de tratamiento
    - Firma del consentimiento informado
    E.4Principal exclusion criteria
    - Somatic disease in acute state
    - Infection in the area of ​​intervention or active systemic infection
    - History of cancerous or precancerous lesions in the area of
    intervention
    - In active treatment with other local treatments in the intervention area
    - In active treatment with immunosuppressants and / or anticoagulants
    - History of allergies to blood derivatives
    - Previous diagnosis of coagulopathies
    - Regular and continued treatment with NSAIDs
    - Positive markers for HCV, AfHBs, HIV-I / II or TP
    - Pregnancy or women of childbearing potential not taking contraceptive measures
    - Lactating women
    - Treatment with monoclonal antibodies
    - Any inability to participate in the study
    - Enfermedad somática en estado agudo
    - Infección en la zona de intervención o infección sistémica activa
    - Antecedentes de lesiones cancerosas o precancerosas en la zona de
    intervención
    - En tratamiento activo con otros tratamientos locales en la zona de intervención
    - En tratamiento activo con inmunosupresores y/o anticoagulantes
    - Antecedentes de alergias a derivados hemáticos
    - Diagnóstico previo de coagulopatías
    - Tratamiento habitual y continuado con AINES
    - Marcadores positivos para VHC, AfHBs, VIH-I/II o TP
    - Embarazo o mujeres en edad fértil que no tomen medidas anticonceptivas
    - Mujeres lactantes
    - Tratamiento con anticuerpos monoclonales
    - Cualquier incapacidad para participar en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Evolution of quality of life at 6 and 8 months measured through the Skindex-29 index: validated scale referring to dermatological diseases
    Evolución de la calidad de vida a los 6 y 8 meses medida a través del índice Skindex-29: escala validada referente a enfermedades dermatológicas
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 and 8 months
    A los 6 y 8 meses
    E.5.2Secondary end point(s)
    1. Evolution of quality of life at 1 and 3 months measured by the Skindex-29 index: validated scale referring to dermatological diseases.
    2. Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar sclerosus lichen (CSS): validated scale
    regarding the diagnosis and response to treatment in front of the LEA.
    3. Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS): validated scale referring to pain.
    4. Evolution of improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I): validated scale referring to the degree of improvement
    subjective of the patient.
    5. Evolution of clinical improvement at 1, 3, 6 and 8 months through the researcher's global assessment (IGA): validated scale referring to
    degree of clinical improvement of the pathology observed by a clinical specialist.
    6. Frequency of relapses at 6 and 8 months of treatment.
    1. Evolución de la calidad vida a los 1 y 3 meses medida a través del índice Skindex-29: escala validada referente a enfermedades dermatológicas.
    2. Evolución de la respuesta al tratamiento a los 1, 3, 6 y 8 meses a través de la escala clínica del liquen vulvar escleroso (CSS): escala validada
    referente al diagnóstico y respuesta a tratamiento frente al LEA.
    3. Evolución del dolor a los 1, 3, 6 y 8 meses medida a través de la escala visual análoga del dolor (VAS): escala validada referente al dolor.
    4. Evolución de la mejora a los 1, 3, 6 y 8 meses a través de la impresión global del paciente (PGI-I): escala validada referente al grado de mejora
    subjetiva del paciente.
    5. Evolución de la mejora clínica a los 1, 3, 6 y 8 meses a través de la evaluación global del investigador (IGA): escala validada referente al
    grado de mejora clínica de la patología objetivada por un especialista clínico.
    6. Frecuencia de recidivas a los 6 y 8 meses de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 1 and 3 months
    2. 1, 3, 6 and 8 months.
    3. 1, 3, 6 and 8 months.
    4. 1, 3, 6 and 8 months.
    5. 1, 3, 6 and 8 months.
    6. 6 and 8 months.
    1. 1 y 3 meses
    2. 1, 3, 6 y 8 meses
    3. 1, 3, 6 y 8 meses.
    4. 1, 3, 6 y 8 meses.
    5. 1, 3, 6 y 8 meses.
    6. 6 y 8 meses.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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
    Clovate (Propionato de clobetasol)
    Clovate (Propionate of clobetasol)
    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
    LVLP
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 Decision2022-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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