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    Summary
    EudraCT Number:2016-003952-63
    Sponsor's Protocol Code Number:LIQUENIA
    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:2017-05-08
    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 number2016-003952-63
    A.3Full title of the trial
    Pilot study of vulval lichen sclerosus treatment by adipose tissue associated with autologous platelet-rich plasma
    Estudio piloto del tratamiento del liquen escleroso vulvar mediante tejido adiposo asociado a plasma rico en plaquetas autólogo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of vulval lichen sclerosus treatment by adipose tissue associated with autologous platelet-rich plasma
    Estudio del tratamiento del liquen escleroso vulvar mediante tejido adiposo asociado a plasma rico en plaquetas autólogo
    A.4.1Sponsor's protocol code numberLIQUENIA
    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 SponsorInstituto de Investigación Sanitaria La Fe
    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 supportInstituto de Investigación Sanitaria La Fe
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigación Sanitaria La Fe
    B.5.2Functional name of contact pointJose Maria Millan Salvador
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Fernando Abril Martorell 106
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46026
    B.5.3.4CountrySpain
    B.5.6E-mailinvestigacion_clinica@iislafe.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 nameAutologous fat graft associatte with autologous platelet rich plasma (PRP)
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    Subdermal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPlatelet-rich plasma (PRP)
    D.3.9.3Other descriptive namePLATELETS, HUMAN BLOOD
    D.3.9.4EV Substance CodeSUB127875
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEASCS
    D.3.9.3Other descriptive nameEXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE (EASCS)
    D.3.9.4EV Substance CodeSUB30158
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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 Clobetasol Propionate 0,05%
    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 Cream
    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 INNCLOBETASOL PROPIONATE
    D.3.9.1CAS number 25122-46-7
    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.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
    Vulval lichen sclerosus
    Liquen escleroso vulvar
    E.1.1.1Medical condition in easily understood language
    Vulval lichen sclerosus
    Liquen escleroso vulvar
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10047761
    E.1.2Term Vulval lichen sclerosus et atrophicus
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the improvement in the elasticity of the fibrosis plaques of patients affected by vulval lichen sclerosus after two infiltrations of fat tissue and autologous platelet-rich plasma.
    Demostrar la mejoría en la elasticidad de las placas de fibrosis de las pacientes afectadas de liquen escleroso vulvar tras dos infiltraciones de tejido graso y plasma rico en plaquetas autólogo.
    E.2.2Secondary objectives of the trial
    Study of vulvar subunits structural improvement; Evaluate structural improvement in the vulvular areas treated; Analysis of the fibrosis and inflammation improvement at 6 months of the first infiltration and 3 months of the second infiltration;To evaluate if there is symptoms improvement at the month, 3 months, 6 months and 12 months of the first infiltration and at 3 and 9 months of the second infiltration;Examine if there is an improvement in quality of life;Determine whether the beneficial effects at the level of symptom reduction following infiltration of the patient's own fat tissue associated with platelet-rich plasma are maintained in the long term (for at least one year from the first infiltration);Later use of the clinical and pain scale of this study in studies of vulvar lichen sclerosus with greater number of patients;Evaluate treatment-derived adverse events during the first year after first infiltration by CRD collection.
    Estudio de la mejoría estructural de las subunidades vulvares afectadas;Evaluar si se produce una mejoría estructural en las zonas vulvares tratadas;Análisis de la mejoría de la fibrosis y de la inflamación;Estudiar si se produce una mejoría de los síntomas al mes, 3 meses, 6 meses y 12 meses de la primera infiltración y a los 3 y 9 meses de la segunda infiltración;Examinar si se produce una mejoría en la calidad de vida;Determinar si los efectos beneficiosos a nivel de reducción de síntomas tras la infiltración del tejido graso de la propia paciente asociado a plasma rico en plaquetas se mantienen a largo plazo (durante al menos un año desde la primera infiltración);Utilización posterior de la escala de afectación clínica y de dolor de este estudio en estudios de liquen escleroso vulvar con mayor número de pacientes;Evaluar los eventos adversos derivados del tratamiento durante el primer año tras la primera infiltración mediante recogida en el CRD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult women between 18 and 70 years old
    Patients with clear clinical and / or histological diagnosis of lichen sclerosus
    Vulvar biopsy existence at some point in patient’s medical history to exclude malignant or pre-malignant disease
    Moderate or severe disease at genital level
    Patients who have had topical treatment for at least three months with 0.05% clobetasol propionate.
    Informed consent previously signed.
    Mujeres adultas entre 18 y 70 años de edad.
    Pacientes con diagnóstico claro clínico y/o histológico de liquen escleroso (LE).
    Existencia de biopsia vulvar en algún momento de su historia clínica a fin de excluir enfermedad maligna o pre-maligna.
    Afectación moderada o severa de la enfermedad a nivel genital.
    Las pacientes que hayan llevado tratamiento tópico durante al menos tres meses con propionato de clobetasol al 0,05%.
    Consentimiento informado firmado previo.
    E.4Principal exclusion criteria
    Pregnant or lactating women
    Alcoholic patients
    Patients with malignant disease diagnosed in the last 5 years
    Patients infected with HIV, HBV and HCV virus
    Injecting drug users
    Patients with serious active infectious diseases.
    Patients with allergy or intolerance recognized for any of the above treatments
    Patients with inflammatory diseases that may affect the vulvar area (Crohn's disease, ulcerative colitis, Psoriasis, Eczema).
    Patients with unrealistic expectations regarding the ultimate benefits of treatment
    Mujeres embarazadas o en periodo de lactancia.
    Pacientes alcohólicas.
    Pacientes con enfermedad maligna diagnosticada en los últimos 5 años.
    Pacientes infectados por los virus VIH, VHB y VHC.
    Usuarios de drogas por vía parenteral.
    Pacientes con enfermedades infecciosas activas graves.
    Pacientes con alergia o intolerancia reconocida a cualquiera de los tratamientos mencionados.
    Pacientes con enfermedades inflamatorias que puedan afectar a la zona vulvar (enfermedad de Crohn, Colitis ulcerosa, Psoriasis, Eczema).
    Pacientes con expectativas poco realistas respecto a los beneficios finales del tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Elasticity of fibrosis plaques in the affected vulvar area
    Elasticidad de las placas de fibrosis de la zona vulvar afectada
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month, 3 months, 6 months and 12 months after treatment.
    Al mes, 3 meses, 6 y 12 meses de la primera infiltración, y a los 3 y 9 meses de la segunda infiltración.
    E.5.2Secondary end point(s)
    Structural improvement of vulvar subunits, histological improvement, improvement in quality of life, improvement of clinical and symptoms, and improvement in scores on clinical scale, pain scale, pruritus scale, and IFS ( Index of sexual function) of Rosen.
    Mejoría estructural de las subunidades vulvares, mejoría histológica, mejoría en la calidad de vida, mejoría de la clínica y los síntomas y mejora en las puntuaciones de la escala de afectación clínica, de la escala de dolor, escala de prurito, y del IFS (índice de función sexual) de Rosen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 month, 3 months, 6 months and 12 months after treatment.
    Al mes, 3 meses, 6 y 12 meses de la primera infiltración, y a los 3 y 9 meses de la segunda infiltración.
    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) 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 No
    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 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
    Last visit of the last subject undergoing the trial
    Última visita del último paciente participando en el ensayo
    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 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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.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
    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 Decision2017-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-12
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