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    Summary
    EudraCT Number:2010-018291-25
    Sponsor's Protocol Code Number:CRC-AGA02
    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:2010-06-24
    Trial results View 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 number2010-018291-25
    A.3Full title of the trial
    INVESTIGATOR-INITIATED, DOUBLE BLIND, TWO-ARMED, PLACEBO-CONTROLLED, RANDOMIZED CLINICAL TRIAL WITH AN OPEN-LABEL EXTENSION PHASE, TO INVESTIGATE EFFICACY OF 5% MINOXIDIL TOPICAL FOAM TWICE DAILY IN MEN WITH ANDROGENETIC ALOPECIA IN THE TEMPLE AND VERTEX REGION CONCERNING HAIR VOLUME OVER 24 / 104 WEEKS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the effectiveness on hair growth and safety of a 5% minoxidil foam versus placebo foam over 24 weeks, when twice dialy applied on the hair thinning sites in male patients with androgenetic alopecia. After the 24 weeks period all willing subjects can participate in the open-label phase of the study, getting 5% minoxidil foam for further 80 weeks.
    A.4.1Sponsor's protocol code numberCRC-AGA02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01319370
    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, Klinik für Dermatologie, Venerologie und Allergologie, CRC
    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 supportMedical grant application, Johnson & Johnson Consumer Co Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité-Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, CRC
    B.5.2Functional name of contact pointKathrin Hillmann
    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 number+4930450 518 267
    B.5.6E-mailkathrin.hillmann@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 Men's Rogaine(R) foam
    D.2.1.1.2Name of the Marketing Authorisation holderMcNEIL-PPC, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameMen's Rogaine(R) foam
    D.3.4Pharmaceutical form Cutaneous foam
    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 INNMINOXIDIL
    D.3.9.1CAS number 38304-91-5
    D.3.9.4EV Substance CodeSUB08982MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCutaneous foam
    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
    Otherwise healthy men with androgenetic alopecia (Hamilton-Norwood Scale IIIvertex to VI) in the temple and vertex area.
    E.1.1.1Medical condition in easily understood language
    Men with hair thinning in the temple AND the vertex region, showing the typical form of androgenetic alopecia. Men should be otherwise healthy.
    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 13.1
    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
    Primary objective is the change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] after 24 weeks
    E.2.2Secondary objectives of the trial
    Change of target area non-vellus hair count in the vertex region (v-TAHC) [n/cm²] compared to baseline after 24, 52, 76 and 104 weeks
    Change of cumulative hair width in non-vellus hair in temple and vertex region (t-TAHW; v-TAHW) [mm/cm²] compared to baseline after 24, 52, 76 and 104 weeks
    Change of t-TAHC, v-TAHC, t-TAHW and v-TAHW comparing 5% MTF and Placebo Topical Foam (plaTF) groups
    Global expert panel rating change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via assessment of global temple and vertex photographs
    Subject rating of change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via global temple and vertex photographs
    Assessing the investigational products safety by means of clinical examination (local intolerance, AE, SAE)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male, age 18 to 70, in general good health.
    - Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale IIIvertex to VI
    - Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject (or a legally acceptable representative), has been informed of all pertinent aspects of the trial.
    - 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.
    - Accepting the Information form plus accepting and signing the Informed Consent form.
    E.4Principal exclusion criteria
    - Known to be hypersensitive to minoxidil, hair dye (p-phenylendiamin), tattoo ink, fragrances, hair gel or any vehicle components
    - Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazol or the like (e. g. Terzolin®) in the target region interfering with the study product or examination method
    - Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the study product (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 study product or examination method (beta blocker, Cimetidine, Diazoxid, Isotretionin, corticosteroids, vitamin A intake above 10000 IU per day)
    - Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Durasteride 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, non-breathable wigs or 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 study product 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)
    - Individuals who are institutionalized by court or regulatory order
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, week 24
    E.5.2Secondary end point(s)
    Change of target area non-vellus hair count in the vertex region (v-TAHC) [n/cm²] compared to baseline after 24, 52, 76 and 104 weeks
    Change of cumulative hair width in non-vellus hair in temple and vertex region (t-TAHW; v-TAHW) [mm/cm²] compared to baseline after 24, 52, 76 and 104 weeks
    Change of t-TAHC, v-TAHC, t-TAHW and v-TAHW comparing 5% MTF and Placebo Topical Foam (plaTF) groups
    Global expert panel rating change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via assessment of global temple and vertex photographs
    Subject rating of change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via global temple and vertex photographs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, week 24, week 52, week 76, week 104
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    24 weeks double-blinded phase with a subsequent 80 weeks open label extension
    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 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 Yes
    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 at week 104 will be the end of the trial.
    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 months8
    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 months8
    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.1.1Number of subjects for this age range: 0
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state70
    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 informed about suitable therapies for AGA treatment.
    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 Decision2010-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-18
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