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: 12 December 2016
• Main ID: EUCTR2009-018109-29-GB
• Date of registration: 04/06/2010
• 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: 06/09/2010
• 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 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.
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:
Subjects presenting with any of the following will not be included in the trial:
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-a-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®, bimatopro

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

Secondary Objective: There are no secondary objectives

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 ID(s)

2009-018109-29-FR

MINALO3004