The efficacy of PROPECIA was demonstrated in men ( 88% Caucasian
) with mild to moderate androgenetic alopecia ( male pattern
hair loss ) between 18 and 41 years of age. In order to
prevent seborrheic dermatitis which might confound the assessment
of hair growth in these studies, all men, whether treated
with finasteride or placebo, were instructed to use a specified,
medicated, tar-based shampoo ( Neutrogena T/Gelฎ** Shampoo
) during the first 2 years of the studies.
There were three double-blind, randomized, placebo-controlled
studies of 12-month duration. The two primary endpoints
were hair count and patient self-assessment; the two secondary
endpoints were investigator assessment and ratings of photographs.
In addition, information was collected regarding sexual
function ( based on a self-administered questionnaire )
and non-scalp body hair growth. The three studies were conducted
in 1,879 men with mild to moderate, but not complete, hair
loss. Two of the studies enrolled men with predominantly
mild to moderate vertex hair loss ( n=1,553 ). The third
enrolled men having mild to moderate hair loss in the anterior
mid-scalp area with or without vertex balding ( n=326 ).
Of the men who completed the first 12 months of the two vertex
baldness trials, 1,215 elected to continue in double-blind,
placebo-controlled, 12-month extension studies. There were
547 men receiving PROPECIA for both the initial study and
first extension periods ( up to 2 years of treatment ) and
60 men receiving placebo for the same periods. The extension
studies were continued for 3 additional years, with 323
men on PROPECIA and 23 on placebo entering the fifth year
of study.
In order to evaluate the effect of discontinuation of therapy,
there were 65 men who received PROPECIA for the initial
12 months followed by placebo in the first 12-month extension
period. Some of these men continued in additional extension
studies and were switched back to treatment with PROPECIA,
with 32 men entering the fifth year of the study. Lastly,
there were 543 men who received placebo for the initial
12 months followed by PROPECIA in the first 12-month extension
period. Some of these men continued in additional extension
studies receiving PROPECIA, with 290 men entering the fifth
year of the study ( see Figure below ).
Hair counts were assessed by photographic enlargements of a representative
area of active hair loss. In these two studies in men with
vertex baldness, significant increases in hair count were
demonstrated at 6 and 12 months in men treated with PROPECIA,
while significant hair loss from baseline was demonstrated
in those treated with placebo. At 12 months there was a
107-hair difference from placebo ( p<0.001, PROPECIA
[n=679] vs placebo [n=672] ) within a 1-inch diameter circle
( 5.1 cm2 ). Hair count was maintained in those
men taking PROPECIA for up to 2 years, resulting in a 138-hair
difference between treatment groups ( p<0.001, PROPECIA
[n=433] vs placebo [n=47] ) within the same area. In men
treated with PROPECIA, the maximum improvement in hair count
compared to baseline was achieved during the first 2 years.
Although the initial improvement was followed by a slow
decline, hair count was maintained above baseline throughout
the 5 years of the studies. Furthermore, because the decline
in the placebo group was more rapid, the difference between
treatment groups also continued to increase throughout the
studies, resulting in a 277-hair difference ( p<0.001,
PROPECIA [n=219] vs placebo [n=15] ) at 5 years ( see Figure
below ).
Patients who switched from placebo to PROPECIA ( n=425 ) had
a decrease in hair count at the end of the initial 12-month
placebo period, followed by an increase in hair count after
1 year of treatment with PROPECIA. This increase in hair
count was less ( 56 hairs above original baseline ) than
the increase ( 91 hairs above original baseline ) observed
after 1 year of treatment in men initially randomized to
PROPECIA. Although the increase in hair count, relative
to when therapy was initiated, was comparable between these
two groups, a higher absolute hair count was achieved in
patients who were started on treatment with PROPECIA in
the initial study. This advantage was maintained through
the remaining 3 years of the studies. A change of treatment
from PROPECIA to placebo ( n=48 ) at the end of the initial
12 months resulted in reversal of the increase in hair count
12 months later, at 24 months ( see Figure below ).
At 12 months, 58% of men in the placebo group had further hair
loss ( defined as any decrease in hair count from baseline
), compared with 14% of men treated with PROPECIA. In men
treated for up to 2 years, 72% of men in the placebo group
demonstrated hair loss, compared with 17% of men treated
with PROPECIA. At 5 years, 100% of men in the placebo group
demonstrated hair loss, compared with 35% of men treated
with PROPECIA.
| Effect
on Hair Count
Number of Hairs in a 1-Inch Diameter Circle
Mean Change + 1 S.E.
|
|
Pooled data
from vertex hair loss studies
1 = finasteride, 1 mg
P = placebo |
|
Patient self-assessment was obtained at each clinic visit from
a self-administered questionnaire, which included questions
on their perception of hair growth, hair loss, and appearance.
This self-assessment demonstrated an increase in amount
of hair, a decrease in hair loss, and improvement in appearance
in men treated with PROPECIA. Overall improvement compared
with placebo was seen as early as 3 months ( p<0.05 ),
with improvement maintained over 5 years.
Investigator assessment was based on a 7-point scale evaluating
increases or decreases in scalp hair at each patient visit.
This assessment showed significantly greater increases in
hair growth in men treated with PROPECIA compared with placebo
as early as 3 months ( p<0.001 ). At 12 months, the investigators
rated 65% of men treated with PROPECIA as having increased
hair growth compared with 37% in the placebo group. At 2
years, the investigators rated 80% of men treated with PROPECIA
as having increased hair growth compared with 47% of men
treated with placebo. At 5 years, the investigators rated
77% of men treated with PROPECIA as having increased hair
growth, compared with 15% of men treated with placebo.
An independent panel rated standardized photographs of the head
in a blinded fashion based on increases or decreases in
scalp hair using the same 7-point scale as the investigator
assessment. At 12 months, 48% of men treated with PROPECIA
had an increase as compared with 7% of men treated with
placebo. At 2 years, an increase in hair growth was demonstrated
in 66% of men treated with PROPECIA, compared with 7% of
men treated with placebo. At 5 years, 48% of men treated
with PROPECIA demonstrated an increase in hair growth, 42%
were rated as having no change ( no further visible progression
of hair loss from baseline ) and 10% were rated as having
lost hair when compared to baseline. In comparison, 6% of
men treated with placebo demonstrated an increase in hair
growth, 19% were rated as having no change and 75% were
rated as having lost hair when compared to baseline.
A sexual function questionnaire was self-administered by patients
participating in the two vertex baldness trials to detect
more subtle changes in sexual function. At Month 12, statistically
significant differences in favor of placebo were found in
3 of 4 domains ( sexual interest, erections, and perception
of sexual problems ). However, no significant difference
was seen in the question on overall satisfaction with sex
life.
In one of the two vertex baldness studies, patients were questioned
on non-scalp body hair growth. PROPECIA did not appear to
affect non-scalp body hair.
A study of 12-month duration, designed to assess the efficacy
of PROPECIA in men with hair loss in the anterior mid-scalp
area, also demonstrated significant increases in hair count
compared with placebo. Increases in hair count were accompanied
by improvements in patient self-assessment, investigator
assessment, and ratings based on standardized photographs.
Hair counts were obtained in the anterior mid-scalp area,
and did not include the area of bitemporal recession or
the anterior hairline.
Clinical studies were conducted in men aged 18 to 41 with mild
to moderate degrees of androgenetic alopecia. All men treated
with PROPECIA or placebo received a tar-based shampoo (
Neutrogena T/Gelฎ** Shampoo ) during the first 2 years
of the studies. Clinical improvement was seen as early as
3 months in the patients treated with PROPECIA and led to
a net increase in scalp hair count and hair regrowth. In
clinical studies for up to 5 years, treatment with PROPECIA
slowed the further progression of hair loss observed in
the placebo group. In general, the difference between treatment
groups continued to increase throughout the 5 years of the
studies.
In a combined analysis of the two studies on vertex baldness,
mean hair count changes from baseline were 91 vs 19 hairs
( PROPECIA vs placebo ) among Caucasians ( n=1,185 ), 49
vs 27 hairs among Blacks ( n=84 ), 53 vs 38 hairs among
Asians ( n=17 ), 67 vs 5 hairs among Hispanics ( n=45 )
and 67 vs 15 hairs among other ethnic groups ( n=20 ).
Patient self-assessment showed improvement across racial
groups with PROPECIA treatment, except for satisfaction
of the frontal hairline and vertex in Black men, who were
satisfied overall.
In a study involving 137 postmenopausal women with androgenetic
alopecia who were treated with PROPECIA ( n=67 ) or placebo
( n=70 ) for 12 months, effectiveness could not be demonstrated.
There was no improvement in hair counts, patient self-assessment,
investigator assessment, or ratings of standardized photographs
in the women treated with PROPECIA when compared with the
placebo group ( see INDICATIONS AND USAGE ).
**Registered trademark of Johnson & Johnson.
