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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00441116
First received: February 27, 2007
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Alopecia
Androgenetic Alopecia
Drug: Dutasteride 0.5mg oral tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Randomised, Double-blind, Placebo-controlled, Parallel Group 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 (Norwood-Hamilton Classification Type IIIv, IV and V)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.


Secondary Outcome Measures:
  • Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.

  • Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.

  • Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.

  • Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.

  • Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.

  • Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.

  • Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.

  • Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.

  • Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.

  • Investigator's Photographic Assessment of Improvement Distribution From Baseline [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.

  • Investigator's Photographic Assessment of Improvements From Baseline Score [ Time Frame: Month 3 and Month 6 ] [ Designated as safety issue: No ]
    Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change.

  • Panel Assessment of Improvement Distribution From Screening [ Time Frame: Baseline to Month 3 and Baseline to Month 6 ] [ Designated as safety issue: No ]

    Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count.

    Score Range -3=greatly decreased to +3=greatly increased. 0=No change.


  • The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 [ Time Frame: Month 3, Month 6 and Month 10 ] [ Designated as safety issue: No ]
    Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value.

  • The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 [ Time Frame: Month 3, Month 6, and Month 10 ] [ Designated as safety issue: No ]
    Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.

  • Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. [ Time Frame: Baseline to Month 6 and Month 10 ] [ Designated as safety issue: No ]
    Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, <0.1, adult, 0.25-0.75; females (f): prepuberty, <0.03, premenopausal, 0.05-0.3, menopausal, <0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, >20; luteal 5-20; postmenopausal, >10 IU/L.

  • Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Sodium, Potassium (mEq/L), and Bicarbonate

  • Laboratory Values: Hematology Assessed at Baseline and 6 Months. [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Comparing Lab values and differences from Baseline to month 6

  • Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL)

  • Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)

  • Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation [ Time Frame: Screening ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

  • Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

  • Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

  • Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

  • Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation [ Time Frame: Month 10 ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?

  • Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

  • Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

  • Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

  • Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive [ Time Frame: Baseline to Month 10 ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

  • Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection [ Time Frame: Baseline to Month 10 ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.

  • Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation [ Time Frame: Baseline to Month 10 ] [ Designated as safety issue: No ]
    In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.


Enrollment: 150
Study Start Date: December 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Dutasteride
Dutasteride
Drug: Dutasteride 0.5mg oral tablets
Dutasteride
Other Name: Dutasteride 0.5mg oral tablets

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441116

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00441116     History of Changes
Other Study ID Numbers: 106377
Study First Received: February 27, 2007
Results First Received: January 20, 2009
Last Updated: August 11, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
dutasteride
Androgenic alopecia
phase 3

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014