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    The EU Clinical Trials Register currently displays   36818   clinical trials with a EudraCT protocol, of which   6079   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-018109-29
    Sponsor's Protocol Code Number:MINALO3004
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-018109-29
    A.3Full title of the trial
    A PHASE 3 MULTI-CENTER PARALLEL DESIGN CLINICAL TRIAL TO COMPARE THE EFFICACY AND SAFETY OF 5% MINOXIDIL FOAM VS. 2% MINOXIDIL SOLUTION IN FEMALES FOR THE TREATMENT OF FEMALE PATTERN HAIR LOSS (ANDROGENETIC ALOPECIA)
    A.4.1Sponsor's protocol code numberMINALO3004
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJohnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 name5% minoxidil topical foam (MTF)
    D.3.2Product code 5% MTF
    D.3.4Pharmaceutical form Cutaneous foam
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNMINOXIDIL
    D.3.9.1CAS number 38304-91-5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Women's Rogaine 2% Minoxidil topical solution
    D.2.1.1.2Name of the Marketing Authorisation holderMcNeil Products Limited
    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 name2% Minoxidil Topical Solution (MTS)
    D.3.2Product code 2% MTS
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNMINOXIDIL
    D.3.9.1CAS number 38304-91-5
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    FEMALE PATTERN HAIR LOSS (ANDROGENETIC ALOPECIA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10068168
    E.1.2Term Androgenetic alopecia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the risk/benefit profile of a 5% minoxidil topical foam (MTF) formulation applied OD for the treatment of female pattern hair loss FPHL) in comparison to 2% minoxidil topical solution (MTS) formulation used BID, using objective efficacy measures and safety assessments.

    E.2.2Secondary objectives of the trial
    There are no secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female, age 18 or older, in general good health;
    2. Exhibits female pattern hair loss based on a discernable decrease in hair density on the top of the scalp, relative to the sides and back of the scalp, with scalp hair density in involved area D3 to D6 on the Savin Density Scale (Appendix 2);
    3. A personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative), has been informed of all pertinent aspects of the trial;
    4. Agree to use an adequate method of birth control which should include but is not
    limited to one or more of the following:
     Systemic birth control, including oral contraceptives, topical contraceptives,
    injectable contraceptives, or contraceptive vaginal ring. Subjects must have been
    using the same type of birth control for at least 3 months prior to entering the
    study and must not change type of birth control during the study;
     Cyproterone acetate as a prescribed contraceptive will be permitted provided that
    the subject has maintained the same regimen for the past 12 months, with no
    change in regimen during the clinical trial;
     Intrauterine device;
     Male partner vasectomy;
     Females who are post-menopausal (for at least one year), have had a
    hysterectomy, bilateral oophorectomy or bilateral tubal ligation do not have to use
    additional birth control methods.
    5. Women of childbearing potential* must show a negative urine pregnancy test at
    Screening Visit. (*includes all women unless one year post-menopause or previously
    surgically sterilized by hysterectomy or oophorectomy, or have had bilateral tubal
    ligation);
    6. Willing to maintain the same hairstyle, hair length, hair color, and hair regimen
    throughout the study;
    7. Subjects who are willing and able to comply with scheduled visits, treatment plan,
    laboratory tests and other trial procedures;
    E.4Principal exclusion criteria
    1. Known to be hypersensitive to minoxidil or to any of the ingredients in minoxidil;
    2. Known allergy to hair dye, or hair dye components;
    3. Clinically relevant history of hypotension (blood pressure <90/60), as determined by the investigator;
    4. Untreated or uncontrolled hypertension (not stable on current medication for past
    three months). Hypertension will be defined as blood pressure >140/90;
    5. Female who is pregnant, planning a pregnancy (during the course of the study) or
    nursing a child;
    6. Within past 12 months, use of 5-α-reductase inhibitors (ex: finasteride or dutasteride) and/or anti-androgens, isotretinoin, immunoglobulins/ immunomodulators (ex:cyclosporin), (for more than 4 continuous weeks), chemotherapy/cytotoxic agents,and/or radiation therapy to the scalp;
    7. Within the past 6 months, use of hair re-growth products, including minoxidil (for
    more than 4 continuous weeks);
    8. Within the past 3 months, use of systemic cimetidine or ketoconazole (for more than 2 continuous weeks);
    9. Within the past 2 months, use of systemic corticosteroids (for more than 2
    consecutive weeks);
    10. Current or prior enrollment in any other investigational medication (drug) study
    within the last six months;
    11. Presence of hair transplants, hair weaves or non-breathable wigs;
    12. History of abnormal pap smear or cervical cancer within the past five years;
    13. Dermatologic disorders of the scalp, including fungal or bacterial infections,
    seborrheic dermatitis, psoriasis, folliculitis, follicular drop-out, etc. that require
    chronic use of medication for control;
    14. Other concomitant types or history of hair loss including, but not limited to telogen effluvium, alopecia areata and scarring alopecia;
    15. Known underlying medical problems that could adversely affect hair growth such as HIV infection, connective tissue disease, inflammatory bowel disease, uncontrolled
    thyroid disease, polycystic ovarian disease, or other endocrine disorders;
    16. Other severe, acute or chronic medical or psychiatric condition that may increase the risk associated with trial participation or investigational product administration or
    may interfere with the interpretation of trial results and, in the judgment of the
    investigator, would make the subject inappropriate for entry into this trial;
    17. Use of anti-seizure meds, beta blockers or vasodilators (ex: diazoxide) if not on
    continuously for 6 months prior to study with no anticipated change during the study;
    18. Use of laser hair removal within past 3 months, or depilatory or waxing within 4
    weeks of baseline visit, or shaving of face within 2 days of baseline visit.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints:

    • Change from baseline in Target Area non-vellus Hair Counts (TAHC), at Week 24

    Safety Endpoints:
    • Evaluation of local intolerance
    • Evaluation for facial hypertrichosis
    • Evaluation of adverse events
    • Evaluation of systemic minoxidil levels
    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) 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 No
    E.8.1.3Single blind Yes
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of Study in a MS of EU is defined as the time at which sufficient subjects have been recruited and completed the study. End of Study in all participating countries is defined as Last Subject Last Visit (LSLV). LSLV is either the date of the last patient visit to complete the study, or the date of the last data point from the last patient received (required for statistical analysis), whichever is the later date.
    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 months11
    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 months11
    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.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 300
    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)
    Standard 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 Decision2010-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-13
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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