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)

• Register: EUCTR
• Last refreshed on: 23 January 2017
• Main ID: EUCTR2009-018109-29-FR
• Date of registration: 27/04/2010
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: 05/07/2010
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018109-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany, United Kingdom

Key inclusion & exclusion criteria

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;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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-a-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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

FEMALE PATTERN HAIR LOSS (ANDROGENETIC ALOPECIA)
MedDRA version: 12.1 Level: LLT Classification code 10068168 Term: Androgenetic alopecia

Intervention(s)

Product Name: 5% minoxidil topical foam (MTF)
Product Code: 5% MTF
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: MINOXIDIL
CAS Number: 38304-91-5
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 5-

Trade Name: Women's Rogaine 2% Minoxidil topical solution
Product Name: 2% Minoxidil Topical Solution (MTS)
Product Code: 2% MTS
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: MINOXIDIL
CAS Number: 38304-91-5
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

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

Main Objective: 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.

Secondary Objective: There are no secondary objectives

Secondary ID(s)

MINALO3004