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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-004130-15
    Sponsor's Protocol Code Number:CRC-AGA-M-A-11
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-004130-15
    A.3Full title of the trial
    Investigator-initiated clinical research trial on the effects of 5% Minoxidil topical foam on gene expression, hair growth and scalp microenvironment in men with androgenetic alopecia
    Investigator-initiierte klinische Studie zur Untersuchung der Effekte von topischem 5% Minoxidil-Schaum auf Gen-Expression, Haarwachstum und Mikromilieu der Kopfhaut bei Männern mit androgenetischer Alopezie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigator-initiated clinical research trial on the effects of 5% Minoxidil topical foam on gene expression, hair growth and scalp microenvironment in men with androgenetic alopecia
    Investigator-initiierte klinische Studie zur Untersuchung der Effekte von topischem 5% Minoxidil-Schaum auf Gen-Expression, Haarwachstum und Mikromilieu der Kopfhaut bei Männern mit androgenetischer Alopezie
    A.3.2Name or abbreviated title of the trial where available
    AGA Array Minoxidil
    AGA Array Minoxidil
    A.4.1Sponsor's protocol code numberCRC-AGA-M-A-11
    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 SponsorCharité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science
    B.1.3.4CountryGermany
    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 supportClinical Research Center for Skin and Hair Science (CRC)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science
    B.5.2Functional name of contact pointDr. Sabine Fimmel
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number0049030450518452
    B.5.5Fax number0049030450518998
    B.5.6E-mailsabine.fimmel@charite.de
    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 Regaine® Männer Schaum
    D.2.1.1.2Name of the Marketing Authorisation holderMcNeil Consumer Healthcare GmbH
    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 nameRegaine Männer Schaum
    D.3.2Product code D11AX01
    D.3.4Pharmaceutical form Cutaneous foam
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMINOXIDIL
    D.3.9.3Other descriptive nameRegaine Männer Schaum
    D.3.9.4EV Substance CodeSUB08982MIG
    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
    Androgenetic Alopecia Hamilton-Norwood IIIv-IV male patients
    Androgenetische Alopezie Hamilton-Norwood IIIv-IV bei männlichen Patienten
    E.1.1.1Medical condition in easily understood language
    Genetically determined hair loss in men
    Anlagebedingter Haarausfall bei Männern
    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 PT
    E.1.2Classification code 10068168
    E.1.2Term Androgenetic alopecia
    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
    -Identifying changes on gene expression level associated with minoxidil treatment with special regard to profiles of genes relevant for AGA treatment and for specific effects of early minoxidil action, respectively (1) minoxidil sulfotransferases, potassium channel regulation (2) inflammation, (3) vasoregulation and (4) sexual hormone production and metabolism;
    E.2.2Secondary objectives of the trial
    -Monitor changes of scalp microenvironment using conventional techniques: skin surface lipid collection, novel approach to assess scalp microenvironment by mini-zone CSSS;
    -Comparing results obtained with novel techniques with clinical observations (e.g., onset and extent of shedding), patient complaints (.e.g., itching, trichodynia) and conventional clinical readouts for assessment of minoxidil-induced hair growth (e.g.macrophotography);
    -Drawing conclusions on whether one of the novel approaches could help provide early clinical read-out parameters of minoxidil efficacy which could shorten the duration of future clinical trials in this field
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •healthy male patients 21 - 45 years of age
    •Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale IIIvertex to IV
    •negative plug test occipital
    •Willing to maintain the same hairstyle, hair length and hair color throughout the study
    •Subjects who are willing and able to comply with scheduled visits, treatment plan, mini-tattoo and other trial procedures
    •Written informed consent of the patients
    E.4Principal exclusion criteria
    •Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components
    •Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazole or the like (e. g. Terzolin®) in the target region interfering with the CTM or examination method
    •Current or 3 months dated back use of topical treatment in the target regions taken for more than 2 consecutive weeks interfering with the CTM (topical corticosteroids, aminexil, minoxidil, estrogens)
    •Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day)
    •Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Dutasteride or a similar product
    •Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp
    •Current or prior enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.
    •Presence of hair transplants, hair weaves or non-breathable wigs and hair bonding
    •Current or 2 months dated back severe diet or presenting a history of eating disorder
    •Any dermatological disorders of the scalp in the target region with the possibility of interfering with the CTM or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy
    •Untreated persisting hypertension
    •Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia
    •Other severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results (e. g. untreated hypothyroidism)
    •Persons who are institutionalized because of legal or regulatory order.
    E.5 End points
    E.5.1Primary end point(s)
    - Gene expression differences on affected and uneffected area of alopecia
    - efficiency of 5% Minoxidil on affected area according hair density and number for a study period of 8 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study and trend of the change in variables during study course (Visit 1 - 9)
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Gene expression level
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    unbehandelte Stelle
    untreated area
    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
    letzte Visite, letzter Proband
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 12
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state12
    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)
    Patients receive Minoxidil foam for one more month after study has ended.
    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 Decision2014-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-29
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