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    Summary
    EudraCT Number:2013-003501-25
    Sponsor's Protocol Code Number:ECM2013
    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:2013-11-12
    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 number2013-003501-25
    A.3Full title of the trial
    Efficacy and safety of a 4% hydroquinone cream (Melanoderm 4%) for the treatment of melasma: a randomized controlled split-face study.
    Ensayo clínico, aleatorizado, según el procedimiento ?split face?, unicéntrico, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad del medicamento tópico Melanoderm crema 4% con hidroquinona al 4% en el tratamiento del melasma facial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of a 4% hydroquinone cream (Melanoderm 4%) for the treatment of melasma.
    Ensayo clínico para evaluar la eficacia y seguridad del medicamento Melanoderm crema 4% con hidroquinona al 4% en el tratamiento del melasma facial.
    A.4.1Sponsor's protocol code numberECM2013
    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 SponsorMesoestetic Pharma group 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 supportMesoestetic Pharma Group S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic S.L.
    B.5.2Functional name of contact pointLiana de Plasencia
    B.5.3 Address:
    B.5.3.1Street Addressc/ Azcona, 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.5Fax number0034914561126
    B.5.6E-maill.plasencia@dynasolucions.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.3.2Product code MelanoDerm 4% Crema
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHYDROQUINONE
    D.3.9.1CAS number 123-31-9
    D.3.9.3Other descriptive nameHYDROQUINONE
    D.3.9.4EV Substance CodeSUB14140MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Facial melasma
    Melasma facial
    E.1.1.1Medical condition in easily understood language
    Facial melasma
    Melasma facial
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10027161
    E.1.2Term Melasma
    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
    To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.
    Evaluar la eficacia de una formulación de Hidroquinona al 4% (Melanoderm 4% Crema) en la reducción del melasma facial.
    E.2.2Secondary objectives of the trial
    To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.
    To assess patient?s satisfaction regarding Melanoderm 4% Crema.
    Evaluar la tolerabilidad de la nueva formulación tópica con Hidroquinona 4% (Melanoderm 4% Crema) aplicada en la cara.
    Evaluar la satisfacción de los pacientes con Melanoderm 4% Crema.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult women aged between 18-75 years old.
    Fitzpatrick phototypes I to IV.
    Presenting noderate to severe facial melasma facial, with a basal MASI Index between 10 and 20.
    Women of childbearing potential must use an adecuate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment.
    Breastfeeding women will not be included in the study.
    Having given freely and expressly her informed consent.
    Mujeres adultas entre 18 y 75 años de edad.
    Fototipo de piel Fitzpatrick I a IV.
    Diagnosticadas de melasma facial de moderado a severo, con un Índice MASI entre 10 y 20 en el momento de la selección.
    Las mujeres potencialmente fértiles deberán utilizar un método adecuado de contracepción para evitar el embarazo y deben tener un test de embarazo negativo con un máximo de 72 horas antes de comenzar el tratamiento del estudio. Las mujeres en periodo de lactancia tampoco podrán ser incluidas en el ensayo.
    Consentimiento informado firmado de forma voluntaria.
    E.4Principal exclusion criteria
    Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products.
    Fitzpatrick phototype V.
    Skin pigmentation diseases different to melasma.
    Evidence of active cancer disease or diagnosis of cancer in the last year.
    Those receiving any topical or oral treatment that could interfere with melasma.
    Pregnant or breastfeeding women, or those expecting to get pregnant during the study.
    Evidence or suspicion of low compliance with the study visits and proecedures.
    Participation in other clinical trial simultaneously or in the previous 3 months.
    Hipersensibilidad al principio activo, hidroquinona, o cualquier de los excipientes de los tratamientos de estudio.
    Fototipo de piel Fitzpatrick V.
    Evidencia de cualquier enfermedad neoplásica activa o que hayan sido diagnosticadas de cáncer en el último año.
    Pacientes que estén recibiendo algún tratamiento, tópico u oral, que pueda interferir con el melasma (esteroides, inmunosupresores, retinoides, tratamientos hormonales,?).
    Mujeres embarazadas, en periodo de lactancia, o que pretendan quedarse embarazadas durante el estudio.
    Evidencia o sospecha de bajo cumplimiento o de no poder cumplir con las visitas y procedimientos de estudio.
    Participación en otro ensayo clínico simultáneamente o en los 3 meses previos a la inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    MASI Index
    Índice MASI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal, week 4, week 8.
    Basal, semana 4 y semana 8.
    E.5.2Secondary end point(s)
    Collection of adverse effects.
    VAS (Visual Analogic Scale).
    Registro de acontecimientos adversos.
    EVA (Escala Visual Analógica).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events will be recorded throughout the study and 30 days after the end of treatment.
    VAS will be completed by the patients at the end of the treatment (week 8).
    Los acontecimientos adversos se registrarán a lo largo de todo el ensayo y hasta 30 días tras la finalización del tratamiento.
    La EAV será completada por los pacientes a la finalización del tratamiento (semana 8).
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Procedimiento Split face
    Split face design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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.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)
    Subjects will be provided with a marketed topical hydroquinone 4% treatment to be applied in the complete skin surface of the face, to unify the skin tone.
    Se proporcionará a los sujetos participantes un medicamento de uso tópicocon hidroquinona 4% autorizado y comercializado a aplicar en toda la superficie de la cara, con objeto de regularizar la tonalidad de la piel.
    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 Decision2014-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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