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STUDY DESIGN
Combination of two
two-year Phase III pivotal vertex studies
(U.S. and International) |
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Initial Study: (Year 1)
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1,553 men, age 18 to 41 |
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Mild to moderate, but not
complete, hair loss in the vertex |
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88% Caucasian, 6% black,
and 6% other (Hispanic, Asian, and other) |
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For study control, all
men were asked to use a specified medicated, tar-based shampoo
(Neutrogena T/Gel®) for the prevention of seborrheic dermatitis |

Efficacy was evaluated by four endpoints:
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Hair count —
computer-assisted, macrophotographic hair count in a one-inch diameter
circle at the leading edge of the thinning area of the vertex of the
scalp |
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Patient self-assessment
questionnaire |
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Investigator assessment |
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Assessment of global
photographs by an expert panel of dermatologists |

Randomized Extension Study: (Year 2)
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The 24-month data
presented in this piece depict results for the finasteride/finasteride
and placebo/placebo groups only |
*Neutrogena T/Gel is a registered trademark
of Johnson & Johnson.
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Additional
clinical information |
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A one-year Phase III study in the
anterior mid-scalp with an open extension for an additional year
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326 men with mild to
moderate hair loss in the anterior mid-scalp with or without vertex
balding (modified Norwood/Hamilton Stages 2, 2v, 2a, 3, and 3v, as
shown) |
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Parallel design to the
two vertex studies with the same study endpoints except:
—
Hair count taken in a 1-cm2 circle
—
Placebo patients crossed over to PROPECIA for the extension study |
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Modified Norwood/Hamilton Scale

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