E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
FEMALE PATTERN HAIR LOSS (ANDROGENETIC ALOPECIA) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10068168 |
E.1.2 | Term | Androgenetic alopecia |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary objectives of the trial |
There are no secondary objectives |
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E.2.3 | Trial contains a sub-study | No |
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.
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. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Change from baseline in Target Area Hair Count |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | No |
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 |
France |
Germany |
United Kingdom |
United States |
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E.8.7 | Trial 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
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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. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |