Clinical Trials Register

Summary
EudraCT Number:	2009-018109-29
Sponsor's Protocol Code Number:	MINALO3004
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:	2010-04-28
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

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2009-018109-29

A.3

Full 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.4.1

Sponsor's protocol code number

MINALO3004

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	5% minoxidil topical foam (MTF)
D.3.2	Product code	5% MTF
D.3.4	Pharmaceutical form	Cutaneous foam
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MINOXIDIL
D.3.9.1	CAS number	38304-91-5
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Woman's Rogaine 2% Minoxidil Topical Solution
D.2.1.1.2	Name of the Marketing Authorisation holder	McNeil Products Limited
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	2% Minoxidil Topical Solution (MTS)
D.3.2	Product code	2% MTS
D.3.4	Pharmaceutical form	Cutaneous solution
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MINOXIDIL
D.3.9.1	CAS number	38304-91-5
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

FEMALE PATTERN HAIR LOSS (ANDROGENETIC ALOPECIA)

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10068168
E.1.2	Term	Androgenetic alopecia

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary objectives of the trial

There are no secondary objectives

E.2.3

Trial contains a sub-study

E.3

Principal 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 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 trial7;
 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.4

Principal exclusion criteria

1. Known to be hypersensitive to minoxidil or to any of the ingredients in topical
minoxidil preparations;
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 or nursing a child, 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 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 facial hair removal within 3 months of the baseline visit or 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 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 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.5.1

Primary 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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In 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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-05-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-07-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-02-15

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