The aim of this Phase III study is to compare the efficacy, safety and tolerability of
dutasteride (0. 5mg) with placebo for 6 months, in Korean male subjects with androgenetic
alopecia in the vertex region, types IIIv, IV and V according to the modified
Norwood-Hamilton Classification.
Subject assessment of change in hair growth and loss.
Panel and investigator photographic assessment of change in hair growth
Hormone measurements of LH at screening and DHT, testosterone, TSH, and T4.
Assessment of sexual functionEfficacy:
• Hair growth assessed by macrophotographic technique (hair count) in the vertex at 3 months.
• Subject assessment of change in hair growth in the vertex at 3 and 6 months (GlaxoSmithKline [GSK] Hair Growth Index [HGI]).
• Subject assessment of change in hair loss and overall appearance at 3 and 6 months (GSK HGI)
• Panel photographic assessment of change in hair growth in the vertex at 3 and 6 months (see figure 2 for areas of the scalp)
• Investigator photographic assessment of change in hair growth (IPAQ) of the vertex at 3 and 6 months.
Safety:
• Assessment of adverse events (AEs) throughout the study
• Vital signs, glucose, electrolytes, haematology (total WBC with differential), indicators of kidney function (creatinine) and liver function (alkaline phosphatase, total bilirubin, ALT, AST) assessed at screening and 6 months.
• Hormone measurements to include LH at screening and DHT, testosterone, TSH, and T4 at screening and 6 months.
• Assessment of sexual function (SFI; A Brief Sexual Function Inventory-Problem Assessment) at every visit.
Inclusion criteria:
- Rationale - The vertex area of the scalp will be evaluated during this study,
therefore the inclusion criterion of Norwood Hamilton areas IIIv, IV or V ensures that
subjects with vertex hair loss will be recruited in line with the primary efficacy
endpoint of change in hair growth in the vertex.
A subject will be eligible for inclusion in this study only if all of the following
criteria apply:
1. Male out-patients aged 18-49 years, inclusive
2. Diagnosis of Male Pattern Hair Loss classified as type IIIv, IV, or V utilising the
modified Norwood-Hamilton classification (Figure 1) (N. B. types IVa and Va are
excluded)
3. Able to comprehend instructions and record required information
4. Will provide signed and dated written informed consent to participate in this
investigation
Exclusion criteria:
- A subject will not be eligible for inclusion in this study if any of the following
criteria apply:
1. Evidence of hypogonadism defined as serum testosterone < 250ng/dl and/or LH
>20mIU/ml Note: If the initial serum testosterone result is < 250ng/dl and the
LH value is normal, the test may be repeated once. Attempts should be made,
where possible, to collect all samples in the morning hours. If the repeat
testosterone result is < 250ng/dl, the subject is not eligible for
participation.
2. Greater than two times the upper limit of normal for ALT or AST, or a bilirubin
greater than 2. 0mg/dl (exception - subjects diagnosed with Gilbert's syndrome
will be eligible to participate in the study)
3. Serum creatinine >1. 8mg/dl
4. Global scalp hair thinning, including occipital areas
5. Scarring of the scalp or any other condition or disease of the scalp or hair,
including diseases of the hair shaft (e. g., uncontrolled seborrheic dermatitis,
tinea infections, other causes of alopecia, prior hair transplants or scalp
reductions, psoriatic dermatitis) and inability to discontinue use of hair
weaving.
6. Subjects who use hair colourants/hair dyes, or have the remaining traces of
colourants in their hair. Subjects must maintain their natural hair colour
throughout the study.
7. Hair length in non-balding areas ≤2cm (3/4 inch) around the vertex region of the
head. Subjects must maintain the same hairstyle throughout the study.
8. History of malignancy within the past five years, except basal cell or squamous
cell carcinoma of the skin
9. Serum PSA level > 2. 0 ng/ml at screening visit.
10. Family history(Father, brothers) of prostate cancer.
11. Active unstable thyroid disease, including subjects on therapy for either
hyperthyroidism or hypothyroidism unless their dose of thyroid medication has
been stable for 3 months and serum TSH is normal
12. Hypersensitivity to any 5 AR inhibitor or drugs chemically related to the study
medication
13. Use of finasteride or other 5 AR inhibitors within the 12 months prior to
screening.
14. Previous use of dutasteride.
15. Use of phytotherapy (e. g. saw palmetto) within 8 weeks prior to screening.
16. Previous use of cytotoxic agents
17. Use of glucocorticoids (inhaled glucocorticoids are allowed; topical steroids are
allowed provided that they are not used on the scalp) within the 3 months prior
to screening
18. Use of the following during the 6 months prior to screening:
- Minoxidil (oral or topical)
- Drugs with anti-androgenic properties (e. g., cyproterone acetate,
spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot
be used during the study but is not an excluded drug when used during the
previous 6 months.
- Topical estrogen, progesterone
- Tamoxifen
- Drugs potentially causing hypertrichosis (e. g., cyclosporine, diazoxide,
phenytoin psoralens)
- Anabolic steroids
- Lithium and phenothiazines
17. Concurrent or regular use during the 4 weeks prior to screening of topical agents
to the scalp (e. g., anti-inflammatories) 18. Participation in any investigational or
marketed drug trial within 30 days preceding the screening phase of this study.
Participation in any other drug trial during the course of this study including the
follow-up period.
19. History or current evidence of drug or alcohol abuse within the 12 months prior
screening 20. History of any illness (including psychiatric) which may impair the
ability to provide informed consent or comply with study requirements 21. History of
any unstable illness or condition that, in the opinion of the investigator, might
confound the results or put the subject at risk.
22. Subjects who are known to be HIV positive (status which includes subjects with
AIDS) 23. Subjects who will not refrain from donating blood until completing the study
follow-up period.
