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    Summary
    EudraCT Number:2010-019881-96
    Sponsor's Protocol Code Number:MINALO3005
    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:2010-08-10
    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 number2010-019881-96
    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. VEHICLE IN FEMALES FOR THE TREATMENT OF FEMALE PATTERN HAIR LOSS (ANDROGENETIC ALOPECIA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in Females for Female Pattern Hair Loss
    A.3.2Name or abbreviated title of the trial where available
    Women’s 5% Minoxidil Foam Trial
    A.4.1Sponsor's protocol code numberMINALO3005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01226459
    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 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 supportJohnson & Johnson Consumer & Personal Products Worldwide
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJohnson & Johnson Consumer & Personal Products Worldwide
    B.5.2Functional name of contact pointRita Wanser
    B.5.3 Address:
    B.5.3.1Street Address185 Tabor Road
    B.5.3.2Town/ cityMorris Plains
    B.5.3.3Post codeNJ 07950
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1973385 0993
    B.5.5Fax number+1973385 4400
    B.5.6E-mailr.wanser@its.jnj.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.3.1Product name5% minoxidil topical foam (MTF)
    D.3.2Product code 5% MTF
    D.3.4Pharmaceutical form Cutaneous foam
    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 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) 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 placeboTopical use (Noncurrent)
    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)
    E.1.1.1Medical condition in easily understood language
    Female Pattern Hair Loss
    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
    To determine the risk/benefit profile of a 5% MTF formulation applied OD for the
    treatment of female pattern hair loss in comparison to foam vehicle used OD, using
    objective and subjective 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.
    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
    taking the same type of birth control for at least 6 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;
    - Abstinence provided that an acceptable method of birth control is used should the
    female subject become sexually active with a male partner;
    - 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. If on hormone replacement therapy (HRT),
    must have been on the same regimen for the past 6 months and agree to remain on
    the same regimen during the study.
    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 color, and hair regimen throughout the
    study. Hair length must remain of sufficient length to not effect determination of hair
    density and subject should discuss with study personnel before changing from
    baseline;
    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, to the ingredients in topical minoxidil
    preparations, or to any vehicle components;
    2. Known allergy to hair dye, or hair dye components used in tattoo;
    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 or within 6 months of delivery, whichever was most recent;
    6. Within past 12 months, use of 5-α-reductase inhibitors (ex: finasteride or dutasteride) and/or anti-androgens,
    isotretinoin or other retinoids;
    7. Use of immunoglobulins/immunomodulators (ex: cyclosporin) (for more than 4
    continuous weeks), or chemotherapy/cytotoxic agents;
    8. Radiation therapy to the scalp;
    9. Within the past 6 months, use of hair re-growth products, including minoxidil (for
    more than 4 continuous weeks);
    10. Within the past 3 months, use of systemic cimetidine or ketoconazole (for more than 2 continuous weeks);
    11. Within the past 2 months, use of systemic corticosteroids (for more than 2
    consecutive weeks) and topical steroids other than to the scalp are permitted as long as this does not exceed 4
    continuous weeks total during the study;
    12. Current or prior enrollment in any other investigational medication (drug) study
    within the last six months;
    13. Presence of hair transplants, hair weaves or desire to continue use of non-breathable wigs;
    14. History of abnormal pap smear or cervical cancer within the past five years;
    15. Dermatologic disorders of the scalp, including fungal or bacterial infections,
    seborrheic dermatitis, psoriasis, folliculitis, etc. that require chronic use of medication
    for control or evidence of follicular drop-out suggestive of a destructive follicular
    condition;
    16. Other concomitant types or history of hair loss including, but not limited to telogen effluvium, alopecia areata
    and scarring alopecia;
    17. 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 (ex:
    hirsutism);
    18. Other severe, acute or chronic medical or psychiatric (ex: committed to an institution on the basis of official
    or judicial orders) conditions 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;
    19. 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;
    20. Use of laser hair removal or any other electronic methods of facial hair removal,
    within 3 months of the baseline visit, or unwillingness to refrain from these methods
    of facial hair removal during the study;
    21. Depilatory or waxing of the face within 4 weeks of every visit;
    22. Shaving of the face within one week of the baseline visit and unwillingness to refrain from shaving for one
    week prior to all study visits;
    23. Use of VANIQA® on the face within 4 weeks of the baseline visit or unwillingness to refrain from use during
    the study;
    24. Use of any topical or ocular prostaglandins (Latisse®, bimatoprost, latanoprost, or other prostaglandin
    ophthalmic solutions) unless on products for 4 months or greater prior to baseline.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints:
    - Change from baseline in Target Area non-vellus Hair Counts (TAHC) at Week 24.
    - Subject assessment of scalp coverage, measured as change from baseline at Week 24 on a 7-point scale, where 0 means no perceived change in scalp coverage, +1 to +3 indicate progressively increasing levels of scalp coverage and -1 to -3 indicate progressively decreasing level.

    Safety Endpoints:
    - Evaluation of local intolerance
    - Evaluation for facial hypertrichosis
    - Evaluation of adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    Change from baseline in Target Area Hair Count
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    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 No
    E.8.1.4Double blind Yes
    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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    United Kingdom
    United States
    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 of the last patient to complete the study, or the date at which 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 years0
    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 years0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 464
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    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 Decision2010-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-30
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