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New 5-Year Study Shows Big Hair Count Difference
Between Men Taking PROPECIA® and Those Who Did Not.
The National Hair Journal 2002
The men were
randomized to receive either PROPECIA® longest controlled clinical trial of a
hair loss treatment ever reported showed that men who took PROPECIA®©
(finasteride 1 mg) compared to men who took a placebo had a considerable
difference in their hair or a placebo. The initial 12-month studies counts after
five years, according to data presented at the 59th Annual Meeting of the
American Academy of Dermatology. The new study showed a difference of 277 hairs
in a one-inch diameter circle of scalp in favor of men treated with PROPECIA® for
five years (n'9) vs. those who received a placebo (n). Baseline hair counts of
all men at the start of the study averaged 876 hairs in the one-inch diameter
circle. "This study provides new, long-term scientific data that PROPECIA® helped
the majority of have," said Keith Kaufman, M.D., senior director, Clinical
Research, Merck Research Laboratories. "The study also was the first controlled
clinical trial to evaluate the course of untreated hair loss over a five-year
period and to show the progressive nature of male pattern hair loss." Made by
Merck & Co., Inc., PROPECIA® is were extended on an annual basis, with only a
small number of men remaining on placebo in subsequent years, as specified in
the study design. Men who completed each one-year extension were given the
opportunity to enroll in the next one-year extension, for up to five years. The
five year data presented focused on the results of men who continued on the
same therapy-either PROPECIA® or placebo-for the entire five years. The studies
assessed the efficacy of PROPECIA® by four separate endpoints: Hair counts in a
one-inch diameter circle of the scalp; assessments of "before" & "after"
photographs by a panel of dermatologists; men with predominantly vertex male
pat-patient questionnaires and investigator tern hair loss keep the amount of
hair they assessments of changes in scalp hair growth. The effectiveness of
PROPECIA® vs., placebo was demonstrated as follows: indicated for the treatment of
certain types of hair loss in men. PROPECIA® is a once-a day treatment and is the
only pill for male pattern hair loss approved by the Food and Drug
Administration. The five-year data are from investigational extension studies of
double-blind placebo-controlled clinical trials that first demonstrated the
safety and efficacy of PROPECIA® in 1,553 men age 18 to) of men treated with
PROPECIA® (n'9) and men on placebo (n ) at the
end of the five-year study rated 90 percent of men treated with PROPECIA® as
having had no further visible hair loss compared to baseline vs. 25 percent of
men on placebo.
Patient questionnaires:
Questionnaires completed at five years by men on PROPECIA® (n'4) and by men on
placebo (n) showed that men treated with PROPECIA® indicated a higher level of
satisfaction with the appearance of their hair overall (63 percent vs. 20
percent), the hair on top of their heads (59 percent vs. 13 percent) and their
frontal hairline (48 percent vs. 7 percent). Men treated with PROPECIA® were more
likely to say that: their bald spot was getting smaller (61 percent vs. 20
percent); the appearance of their hair had improved (77 percent vs. 40 percent);
they had experienced increased hair growth (75 percent vs. 40 percent) and their
hair loss had slowed (90 percent vs. 67 percent).
Investigator
assessments:
Physician investigators who evaluated the
men treated with PROPECIA® (n'9) and men on placebo (n ) at the end of five years
determined that 77 percent of the men treated with PROPECIA® had increases in
scalp hair, compared with 15 percent of men on placebo.
Hair count: At the start of the studies,
baseline hair counts averaged 876 hairs in a one-inch diameter area of scalp. By
the end of the first year, men taking PROPECIA® had an average of 126 more hairs
than men taking placebo. This difference continued to grow, and, by the end of
the fifth year, the net difference between the groups increased to 277 hairs
in favor of the men taking PROPECIA®. At the end of the fifth year, 65 percent of
men taking PROPECIA® (n'9) maintained or improved their hair count compared to
their hair count at the start of the studies, while all of the men on placebo
(n)
Conclusions from the 5 year study presented
at the American Academy of Dermatology Meeting in Washington, DC showed overall
good results with PROPECIA®. However some medical sources felt that if you don't
get some results with PROPECIA® but you do get great results, other products
should be added to your hair loss arsenal. In addition, you should consider
talking with your doctor about using a higher dose of finasteride.
Here are a few comments that we've received from
men concerning PROPECIA®. PROPECIA® does not work for everyone. Thank you for all
of your responses.
Individual results may vary.
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