Clinical trial NCT00441116: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia
Keywords: dutasteride
Androgenic alopecia
phase 3
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-28
Enrollment: 153
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.
timeFrame: Baseline and Month 3
measure: Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?
timeFrame: Month 3 and Month 6
measure: Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?
timeFrame: Month 3 and Month 6
measure: 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?
timeFrame: Month 3 and Month 6
measure: Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?
timeFrame: Month 3 and Month 6
measure: Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?
timeFrame: Month 3 and Month 6
measure: Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?
timeFrame: Month 3 and Month 6
measure: Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?
timeFrame: Month 3 and Month 6
measure: 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?
timeFrame: Month 3 and Month 6
measure: Investigator's Photographic Assessment of Improvement Distribution From Baseline
timeFrame: Month 3 and Month 6
measure: Investigator's Photographic Assessment of Improvements From Baseline Score
timeFrame: Month 3 and Month 6
measure: Panel Assessment of Improvement Distribution From Screening
timeFrame: Baseline to Month 3 and Baseline to Month 6
measure: The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10
timeFrame: Month 3, Month 6 and Month 10
measure: The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10
timeFrame: Month 3, Month 6, and Month 10
measure: 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.
timeFrame: Baseline to Month 6 and Month 10
measure: Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.
timeFrame: Baseline and Month 6
measure: Laboratory Values: Hematology Assessed at Baseline and 6 Months.
timeFrame: Baseline and Month 6
measure: Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.
timeFrame: Baseline and Month 6
measure: Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.
timeFrame: Baseline and Month 6
measure: Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation
timeFrame: Screening
measure: Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation
timeFrame: Baseline
measure: Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation
timeFrame: Month 3
measure: Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation
timeFrame: Month 6
measure: Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation
timeFrame: Month 10
measure: Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive
timeFrame: Baseline to Month 6
measure: Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection
timeFrame: Baseline to Month 6
measure: Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation
timeFrame: Baseline to Month 6
measure: Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive
timeFrame: Baseline to Month 10
measure: Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection
timeFrame: Baseline to Month 10
measure: Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation
timeFrame: Baseline to Month 10
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: