A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: Dutasteride 0.5 mg
Intervention description: Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of Dutasteride and it will be packaged in high-density polyethylene (HDPE) bottles with plastic child-resistant closures.
Intervention MeSH terms: Dutasteride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Male
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: male pattern hair loss; hair growth; hair restoration; Dutasteride; Androgenetic alopecia; safety; efficacy

Summary:

      This is a multicentre, open-label study to assess the safety, tolerability, and efficacy of
      0.5 mg Dutasteride administered once daily for 52 weeks in men with Androgenetic Alopecia
      types III vertex, IV and V per the Norwood-Hamilton classification. The study consists of a
      Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks). A subject who
      completes the full course of study treatment and the final study visit (Week 52; Visit 7)
      will be considered as study completion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male outpatient, 20 to 50-years-old, inclusive (at the time of obtaining consent).

          -  AGA classified as Type III vertex, IV, or V (excluding Type IV anterior and V
             anterior) utilizing the Norwood-Hamilton classification.

          -  Fluent and literate in Japanese with the ability to comprehend and record information
             on the PAS SFI and DLQI questionnaires.

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2 x upper limit
             of normal (ULN); alkaline phosphatase and bilirubin <=1.5 x ULN (isolated bilirubin
             >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).

          -  Willing to comply with study requirements, including maintaining the same hair color
             and hairstyle throughout the study- a) subjects who use hair colorants/hair dyes may
             continue to do so; however, there should be no traces of hair color remaining on the
             scalp at the time of study visits. b) hair length in nonbalding areas should be >=2 cm
             (0.75 inch) around the vertex region of the head at the time of study visits.

          -  Able to swallow and retain oral medication

        Exclusion Criteria:

          -  Evidence of hypogonadism defined as serum testosterone <250 Nanogram/decilitre (ng/dl)
             at Screening.

          -  Unstable liver disease (chronic stable hepatitis B and C are acceptable if subject
             otherwise meets entry criteria).

          -  History of renal insufficiency or Serum creatinine >1.5 x ULN at Screening.

          -  History of malignancy within the past 5 years, except basal cell or squamous cell
             carcinoma of the skin.

          -  History of prostate cancer before the age of 50 years in a first degree relative.

          -  Serum PSA level >2.0 nanogram/millilitre (ng/mL) at Screening.

          -  History of breast cancer or clinical breast examination suggestive of malignancy.

          -  Active unstable thyroid disease, including subjects on therapy for either
             hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been
             stable for at least 3 months.

          -  Any unstable, serious co-existing medical condition(s) including, but not limited to,
             myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias,
             clinically evident congestive heart failure, or cerebrovascular accident within 6
             months prior to Screening; uncontrolled diabetes or peptic ulcer disease which is
             uncontrolled by medical management, and subjects who are known to be acquired
             immunodeficiency syndrome [AIDS](including subjects with a diagnosis of human
             immunodeficiency virus (HIV) positive).

          -  History or current evidence of any serious and/or unstable pre-existing medical or
             psychiatric disorder, or other conditions that could, in the opinion of the
             investigator or GSK medical monitor, interfere with the subject's safety, obtaining
             informed consent, or compliance with study procedures. Note: the investigator may
             consult with GSK medical monitor if a condition could interfere with the subject's
             safety.

          -  Clinically relevant abnormal finding on the Screening electrocardiogram (ECG).

          -  Global scalp hair thinning, including occipital areas.

          -  Scarring of the scalp, including prior hair transplant or scalp reduction, or any
             other condition or disease of the scalp or hair, including diseases of the hair shaft
             (e.g., tinea infection, nonandrogenetic-cause of alopecia, psoriatic dermatitis or
             other psoriatic lesions, or uncontrolled seborrheic dermatitis).

          -  History of hair transplantation at any time to correct AGA or use of hair weaving
             within 6 months prior to Screening.

          -  History or evidence of hair loss other than AGA (e.g., due to an auto-immune,
             endocrine, mechanical or infectious process, or secondary to a scalp dermatological
             disorder).

          -  Use of any cosmetic product aimed at improving or correcting the signs of hair loss
             (e.g., scalp preparations with claims aiming at improved hair growth) within 2 weeks
             prior to Screening.

          -  Use of light or laser treatments on the scalp (e.g., light emitting diode [LED] lamps)
             within 3 months prior to Screening.

          -  Hypersensitivity to any 5 alpha-reductase (5AR) inhibitor or drugs chemically related
             to the study treatment.

          -  Use of Dutasteride within 18 months prior to Screening, or use of finasteride within
             12 months prior to Screening.

          -  Previous use of systemic cytotoxic agents.

          -  Use of glucocorticoids (inhaled glucocorticoids are allowed; topical corticosteroids
             are allowed provided that they are not used on the scalp) within 3 months prior to
             Screening.

          -  Use of the following during the 6 months prior to Screening: Minoxidil (oral or
             topical), Carpronium chloride, Systemic drugs with anti-androgenic properties (e.g.,
             cyproterone acetate, spironolactone, ketoconazole, flutamide, and bicalutamide). Use
             of ketoconazole shampoo on the scalp is prohibited during the study, but use before
             Screening is not a reason for exclusion. Cimetidine is prohibited during the study,
             but use before Screening is not a reason for exclusion, Topical estrogen or
             progesterone, Topical prostaglandin analogs on the scalp, Tamoxifen, Drugs potentially
             causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens), Drugs
             potentially causing hypotrichosis or telogen effluvium (e.g., valproic acid), Anabolic
             steroids, Lithium or phenothiazines.

          -  Participation in any investigational or marketed drug or device trial within 1 month
             prior to Screening for this study. Including participation in any trial for
             Dutasteride and administration of active drugs (Dutasteride or finasteride) prior to
             Screening for this study. In addition, subjects must not participate in any other drug
             or device trials during the course of this study.