Finasteride Treatment of Female Pattern Hair Loss

Abstract

To evaluate the efficacy of oral finasteride therapy associated with an oral contraceptive containing drospirenone and ethinyl estradiol in premenopausal women with female pattern hair loss.
Outpatient consultation for hair disorders at the Department of Dermatology, University of Bologna.
Thirty-seven women with female pattern hair loss were treated with oral finasteride, 2.5 mg/d, while taking an oral contraceptive containing drospirenone and ethinyl estradiol. Treatment efficacy was evaluated using global photography and the hair density score from videodermoscopy. A self-administered questionnaire was used to assess patient evaluation of treatment effectiveness.
At 12-month follow-up, 23 of the 37 patients were rated as improved using global photography (12 were slightly improved, 8 were moderately improved, and 3 were greatly improved). No improvement was recorded in 13 patients. One patient experienced worsening of the condition. There was a statistically significant (P = .002) increase in the hair density score in 12 patients. No adverse reactions to the drug were reported.
Sixty-two percent of the patients demonstrated some improvement of their hair loss with the use of finasteride, 2.5 mg/d, while taking the oral contraceptive. It is unclear whether the success was due to a higher dosage of finasteride (2.5 mg instead of 1 mg) or to its association with the oral contraceptive containing drospirenone, which has an antiandrogenic effect. Further studies are necessary to understand which patterns of female pattern hair loss respond better to this treatment.

Full text

STUDY
Finasteride Treatment of Female Pattern Hair Loss
Matilde Iorizzo, MD; Colombina Vincenzi, MD; Stylianos Voudouris, MD;
Bianca Maria Piraccini, MD, PhD; Antonella Tosti, MD
Objective: To evaluate the efficacy of oral finasteride
therapy associated with an oral contraceptive contain-
ing drospirenone and ethinyl estradiol in premeno-
pausal women with female pattern hair loss.
Setting: Outpatient consultation for hair disorders at the
Department of Dermatology, University of Bologna.
Patients and Intervention: Thirty-seven women with
female pattern hair loss were treated with oral finaste-
ride, 2.5 mg/d, while taking an oral contraceptive con-
taining drospirenone and ethinyl estradiol. Treatment ef-
ficacy was evaluated using global photography and the
hair density score from videodermoscopy. A self-
administered questionnaire was used to assess patient
evaluation of treatment effectiveness.
Results: At 12-month follow-up, 23 of the 37 patients
were rated as improved using global photography (12 were
slightly improved, 8 were moderately improved, and 3
were greatly improved). No improvement was recorded
in 13 patients. One patient experienced worsening of the
condition. There was a statistically significant (P=.002)
increase in the hair density score in 12 patients. No ad-
verse reactions to the drug were reported.
Conclusions: Sixty-two percent of the patients demon-
strated some improvement of their hair loss with the
use of finasteride, 2.5 mg/d, while taking the oral con-
traceptive. It is unclear whether the success was due to
a higher dosage of finasteride (2.5 mg instead of 1 mg)
or to its association with the oral contraceptive contain-
ing drospirenone, which has an antiandrogenic effect.
Further studies are necessary to understand which pat-
terns of female pattern hair loss respond better to this
treatment.
Arch Dermatol. 2006;142:298-302
F
EMALE PATTERN HAIR LOSS
(FPHL), the most common
form of hair loss, affects up
to 50% of women during
their life.
1
Although hair
thinning in women with FPHL may be dif-
fuse, 3 different clinical patterns have been
described: the Christmas tree pattern,
2
the
Ludwig pattern,
3
and the Hamilton pat-
tern.
4
Patients who experience hair thin-
ning complain of social anxiety and em-
barrassment. If left untreated, FPHL may
be rapidly progressive.
Treatment for FPHL consists mainly of
topical minoxidil, which is effective
5
but
sometimes is not well accepted by the pa-
tient. The efficacy of oral antiandrogens
is not well established. Although cyprot-
erone acetate is prescribed in Europe to
treat FPHL,
6-8
its efficacy is still contro-
versial. A controlled 12-month random-
ized trial
9
compared the effects of cyprot-
erone acetate, 52 mg/d, with 2% topical
minoxidil in FPHL. All the patients took
oral contraceptives. After 6 months of
treatment, minoxidil was effective in
women with a low body mass index and
the absence of hyperandrogenism. Cy-
proterone was effective when other signs
of hyperandrogenism were present and
when body mass index was high.
In a recent study,
10
treatment with oral
antiandrogens (spironolactone and cy-
proterone and oral contraceptives in pre-
menopausal women) produced hair re-
growth in 35 (44%) of 80 women with
FPHL.This study showed no relationship
between response to treatment and pa-
tient age, menopausal status, and serum
hormone levels. Spironolactone (100-
200 mg/d) and cyproterone acetate (50-
100 mg/d) produced similar results. In a
small 12-month randomized trial,
11
flu-
tamide was reported to be effective at 250
mg/d and was better than cyproterone ac-
etate, 50 mg/d, and finasteride, 5 mg/d. We
report herein our experience with finas-
teride, 2.5 mg/d, taken with an oral con-
traceptive containing drospirenone and
ethinyl estradiol in 37 premenopausal
women with FPHL.
For editorial comment
see page 362
Author Affiliations:
Department of Dermatology,
University of Bologna,
Bologna, Italy.
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METHODS
STUDY PATIENTS AND DESIGN
Thirty-seven premenopausal women with FPHL seen for con-
sultation regarding hair loss were enrolled in this study
(
Table 1). The thinning hair was not associated with in-
creased shedding, and the pull test result was negative. Other
inclusion criteria were normal androgen levels and ovulatory
cycles, normal iron and ferritin levels, and negative thyroid
function test results. Patients affected by acne or hirsutism
were excluded.
After providing informed consent, patients were pre-
scribed finasteride, 2.5 mg/d, and an oral contraceptive con-
taining drospirenone, 3 mg, and ethinyl estradiol, 30 µg (Yas-
min; Schering AG Germany, Berlin, Germany). All 37 women
had refused to apply topical minoxidil. Camacho
12
reported good
results with this finasteride dose in patients with FPHL. Fin-
asteride treatment, which is teratogenic, requires oral contra-
ception to prevent pregnancy. Ethinyl estradiol–drospir-
enone, which has antiandrogenic activity, was selected because
of its possible adjuvant effect on FPHL.
EVALUATION PROCEDURES
Global photography, using a Nikon-Canfield D1 camera with
a Nikon 60-mm f2.8 lens (Nikon Inc, Melville, NY), was per-
formed at baseline and after 12 months of treatment. The pa-
tient’s head was placed in a stereotactic device to ensure con-
sistent positioning and photographic distance. Pictures obtained
at 12 months were compared with those obtained at baseline
and rated by one of us (M.I.), who was not involved in the clini-
cal study. A 7-point scale was used to evaluate hair density in
response to treatment
13
: −3, greatly decreased; −2, moderately
decreased; −1, slightly decreased; 0, no change; 1, slightly in-
creased; 2, moderately increased; and 3, greatly increased.
Hair density score at baseline and after 12 months was evalu-
ated using computerized light videodermoscopy (FotoFinder
dermoscope; Teachscreen Software GmbH, Bad Birnbach, Ger-
many) with ⫻20 magnification lenses. Probed images were digi-
tized and stored. To assess the hair density score, we adapted
the scale proposed by de Lacharrière et al
14
to our instrument.
The reference scores for hair density were obtained by count-
ing the number of hairs on 1 side from center parting within
the same area at the vertex (cross between nose line and ear
implantation): 1, baldness (⬍15 hairs); 2, very low hair den-
sity (15-20 hairs); 3, low hair density (21-30 hairs); 4, me-
dium hair density (31-40 hairs); 5, high hair density (41-50
hairs); and 6, very high hair density (⬎50 hairs).
One of us (C.V.) showed the patients their photographs at
baseline and at 12 months and requested that they assess the
results of treatment using a self-administered questionnaire. They
were questioned about their satisfaction, the appearance of their
hair, the stabilization of hair loss, and the promotion of hair
growth using the 7-point scale described previously herein.
STATISTICAL ANALYSIS
A t test for matched samples was run on hair density values to
corroborate the qualitative findings.
RESULTS
The patients ranged in age from 19 to 50 years (mean,
33.7 years) (Table 1). After 12 months, 23 of the 37 pa-
tients were rated as improved using global photography
(12 were slightly improved, 8 were moderately im-
proved [
Figure 1], and 3 were greatly improved
[
Figure 2]). No improvement was recorded in 13 pa-
tients. One patient experienced worsening of the condi-
tion despite treatment. Hair density scores increased in
12 patients (
Figure 3) from a mean density of 4.5 at
baseline to 4.8 at 12 months (t=−3.375; P=.002). Using
the self-administered questionnaire, 29 patients judged
their condition as improved and 8 as stabilized. None of
the women considered their condition worsened
(
Table 2). No patients experienced adverse reactions
during treatment.
COMMENT
Finasteride is a 5␣-reductase type II inhibitor currently
approved to treat male androgenetic alopecia at a dos-
age of 1 mg/d. Because of the potential risk of terato-
genicity in a male fetus,
15
finasteride is contraindicated
Table 1. Characteristics of 37 Women
With Female Pattern Hair Loss
Patient
Age, y
Baseline Clinical
Pattern
12-mo
GPA
(−3 to ⴙ3)
Hair Density Score
Baseline 12 mo
39 Christmas tree 1 4 4
25 Ludwig I 2 5 6
38 Ludwig I 0 5 5
34 Christmas tree 0 5 5
24 Christmas tree 0 5 5
24 Ludwig II 2 4 5
30 Ludwig I 2 4 5
28 Ludwig I 0 4 4
22 Ludwig II 2 3 4
30 Christmas tree 1 4 4
38 Christmas tree 1 5 5
26 Ludwig I 0 5 5
29 Christmas tree 0 5 5
44 Christmas tree 0 5 5
42 Ludwig II 3 4 5
48 Ludwig I 1 5 5
42 Ludwig I 1 5 5
47 Ludwig II 2 3 4
43 Ludwig I 0 5 5
41 Ludwig I −1 5 4
43 Ludwig I 0 5 5
34 Christmas tree 1 4 5
19 Christmas tree 2 4 5
27 Christmas tree 3 4 6
50 Ludwig I 0 5 5
30 Christmas tree 2 5 6
27 Ludwig I 1 5 5
21 Ludwig II 3 3 5
31 Christmas tree 1 5 5
25 Ludwig I 0 5 5
48 Christmas tree 1 5 5
32 Ludwig II 0 4 4
36 Christmas tree 1 5 5
36 Christmas tree 1 5 5
38 Christmas tree 1 5 5
29 Christmas tree 0 4 4
29 Christmas tree 2 4 5
Abbreviation: GPA, global photography assessment.
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in women of childbearing potential. The efficacy of fin-
asteride in FPHL is still controversial.
A multicenter, double-blind, placebo-controlled, ran-
domized study
16
of finasteride, 1 mg/d, in postmeno-
pausal women with FPHL showed negative results in in-
creasing hair growth and slowing the progression of hair
thinning. After 12 months of treatment, patients in the
finasteride and placebo groups had a modest decrease in
hair count from baseline. Scalp biopsies also revealed no
differences in the anagen-telogen ratio and the terminal
hair–miniaturized hair ratio. In this study, the lack of ef-
ficacy of finasteride may have been related to the older
age of the patients. Hair thinning may not be androgen
dependent in senescent scalps. Moreover, in this study
with negative findings, finasteride was administered at
a dosage of 1 mg/d, which might be inadequate for FPHL.
Recently, noncontrolled studies
12,17-19
indicated that
finasteride therapy can be effective in premenopausal and
postmenopausal women with and without signs of hy-
perandrogenism. Camacho
12
reported hair regrowth us-
ing finasteride, 2.5 mg/d, in 41 women with FPHL and
SAHA (seborrhea, acne, hirsutism, and alopecia) syn-
drome. Thai and Sinclair
17
administered finasteride at a
dosage of 5 mg/wk (⬍1 mg/d) to a 67-year-old post-
menopausal woman without signs of hyperandrogen-
ism and with Ludwig FPHL. After 12 months of treat-
ment the patient showed a significant increase in hair
density. Shum et al
18
administered finasteride to 4 women
with hyperandrogenism at a dosage of 1.25 mg/d. Two
of these patients had a Ludwig-type FPHL, and the other
2 had a Hamilton pattern. Only 2 of the women were post-
menopausal, but the others had a history of infertility with
irregular menses. Increased hair growth and decreased
progression of hair loss were observed in all the patients
after 6 months and 1, 2, and 2.5 years of treatment, re-
spectively. The efficacy of finasteride in postmeno-
pausal normoandrogenic women with FPHL was re-
ported by Trueb
19
as early as after 6 months of treatment.
Finasteride was administered at 2.5 mg/d in 4 women, 1
with the Christmas tree pattern and 3 with the Ludwig
pattern, and finasteride, 5 mg/d, in 1 woman with the
Hamilton pattern.
A recent case report
20
also indicated that the dual 5␣-
reductase inhibitor dutasteride, 0.5 mg/d, can improve
FPHL. All these studies of oral antiandrogens in pre-
menopausal women with FPHL used oral contraception
to prevent pregnancy. However, different contracep-
tives were used, and information about a possible effect
of these agents on treatment efficacy is lacking.
In the present study, 62% of patients demonstrated
some improvement of their hair loss after 1 year of treat-
ment with finasteride, 2.5 mg/d, taken with an oral con-
traceptive containing drospirenone and ethinyl estra-
diol (32% slightly improved, 22% moderately improved,
and 8% greatly improved). Finasteride was well toler-
ated compared with the other oral antiandrogens, and
BA
Figure 1. Christmas tree pattern of hair loss shows moderate improvement compared with baseline (A) after 12 months of oral finasteride treatment (B).
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none of the patients reported adverse effects. This treat-
ment was well accepted by the patients, who judged the
results to be even better than did the investigators. The
patient’s opinion being generally more optimistic than
that of the investigator is not surprising. In double- blind
clinical trials on the efficacy of finasteride on male an-
drogenetic alopecia,
13
patients treated with placebo re-
ported improvement of their condition.
The efficacy of finasteride in two thirds of our pre-
menopausal women may be due to the higher dosage used.
The contraceptive contains drospirenone, a progestin ana-
log of spironolactone. It is possible that even at a very
low dosage (3 mg), drospirenone might have had an ad-
ditional effect in promoting hair growth. Owing to its an-
tiandrogenic and diuretic activities, this pill may be use-
ful for FPHL, but it is also well accepted because it provides
weight stability or even loss.
21
The potential risk of tera-
togenicity of finasteride in women with childbearing po-
tential requires oral contraception. We used the same con-
traception in all the patients to avoid the confounding
role of contraceptive pills containing progestins with pos-
sible androgenic activity.
BA
Figure 2. Ludwig pattern of hair loss shows great improvement compared with baseline (A) after 12 months of oral finasteride treatment (B).
BA
Figure 3. Improvement in the hair density score compared with baseline (A) at 12 months of oral finasteride treatment (B).
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Although our study is not randomized, blinded, and
placebo controlled and does not include scalp biopsies,
the clinical results using global photography, hair den-
sity scores, and patient self-assessment provide a basis
for future work. Further studies are needed to establish
the optimal dosage and mode of administration of fin-
asteride in premenopausal women and to definitively as-
sess the efficacy of this drug compared with oral anti-
androgens.
Accepted for Publication: November 1, 2005.
Correspondence: Antonella Tosti, MD, Department of
Dermatology, University of Bologna, Via Massarenti,
1-40138 Bologna, Italy (tosti@med.unibo.it).
Author Contributions: Study concept and design: Iorizzo
and Tosti. Acquisition of data: Voudouris. Analysis and in-
terpretation of data: Iorizzo, Vincenzi, and Tosti. Draft-
ing of the manuscript: Iorizzo, Piraccini, and Tosti. Criti-
cal revision of the manuscript for important intellectual
content: Iorizzo and Tosti. Study supervision: Iorizzo
and Tosti.
Financial Disclosure: None.
Acknowledgment: We thank Gabriella Fabbrocini, MD, Uni-
versity of Naples (Naples, Italy), for statistical analysis.
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Table 2. Patient and Investigator Assessments
of FPHL After 12 Months of Treatment*
Patient
Assessment
(Questionnaire)
Investigator
Assessment
(GPA)
Improvement (⫹1, ⫹2, ⫹3) 29 23
Stabilization (0) 8 13
Worsening (−1, −2, −3) None 1
Abbreviations: FPHL, female pattern hair loss; GPA, global photography
assessment.
*Data are given as numbers.
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