A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: Dutasteride 0.5mg oral tablets
Intervention description: Dutasteride
Intervention MeSH terms: Dutasteride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 153.0
Sex: Male
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: dutasteride; Androgenic alopecia; phase 3

Summary:

      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.
    

Eligibility criteria:

        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.