FEMALE PATTERN HAIR LOSS (ANDROGENETIC ALOPECIA) MedDRA version: 13.1 Level: PT Classification code 10068168 Term: Androgenetic alopecia System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Eligibility
Sex/Gender
All
Inclusion 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. 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 464 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
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 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-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 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 ref
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: There are no secondary objectives.;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;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in Target Area Hair Count;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
France, Germany, United Kingdom, United States
Contacts
Public ContactRita Wanser
Johnson & Johnson Consumer & Personal Products Worldwide
Outcome results
None listed