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2
Introduction
Hair loss can be a considerable psychological
and social problem for those affected.
1,2
Much effort and investment has been put
into attempts to develop efficient
pharmaceutical and other treatments for
hair loss. In most cases, however, the results
have been disappointing.
Hair loss may result from drug treatment
(cytostatics), pregnancy (telogen effluvium),
alopecia areata or different types of
dermatological diseases.
3
The most common form of hair loss is
androgenic alopecia or hereditary hair loss,
also called male hair loss. Most men will
have this form of hair loss, but the stage at
which the process starts varies considerably.
In 5% of the male population it starts before
the age of 20, normally bitemporally and
later over the vertex. Androgenic alopecia is
due to a genetically determined sensitivity
to androgens. The androgenic effect is
mediated through an increase in 5-α-
reductase activity and formation of
increased amounts of dihydrotestosterone
from testosterone locally in the hair follicles.
This process causes hair loss.
4
Three main treatment schedules are
available today: treatment with the drugs
minoxidil (topical) or finasteride (oral), or
hair transplantation. The two drugs have
been undergoing a number of controlled
clinical trials.
5 – 7
Minoxidil is registered in
The Journal of International Medical Research
2001; 29: 2 – 6
Efficacy and Tolerability of Hairgain
®
in
Individuals with Hair Loss: a Placebo-
controlled, Double-blind Study
E THOM
PAREXEL Medstat AS, Lillestrøm, Norway
This randomized, placebo-controlled,
double-blind study was designed to
investigate the efficacy and tolerability of
a new agent for the treatment of hair loss,
based on a marine protein, minerals and
vitamins. Sixty subjects with hair loss of
different aetiologies participated in the
6-month blinded phase of the study.
Objective assessments indicated that the
treatment was effective and subjective
assessments showed a statistically
significant positive effect of treatment.
Exposure to the active preparation for a
further 6 months in an open phase
indicated a further improvement in hair
growth. Exposure of the patients
previously treated with placebo to the
active preparation for 12 months gave
similar results. Tolerability was good and
no side-effects were reported. The product
investigated may provide an alternative
to pharmacotherapy for the treatment of
hair-loss problems in individuals with
androgenic alopecia.
KEY WORDS: NATURAL SUBSTANCE; HAIR LOSS; ALOPECIA; ANDROGENIC ALOPECIA
3
E Thom
Treatment of hair loss
Norway, while finasteride is registered in the
USA and a number of other countries for
the treatment of androgenic alopecia.
Finasteride is not yet on the market in
Norway.
A number of questionable remedies have
‘over the years’ been available for the
treatment of hair loss.
Hairgain
®
is a new dietary supplement
developed in Norway containing a marine
protein extract and several different
vitamins and minerals. Based on favourable
effects on hair loss seen in open studies, it
was decided to carry out a placebo-controlled
double-blind trial in subjects with hair-loss
problems. To our knowledge this is the first
controlled study carried out with Hairgain
®
.
Subjects and methods
SUBJECTS
Sixty volunteers of both sexes, aged 18 years
or more, were recruited to the study through
an advertisement in a local newspaper. All
had had hair-loss problems for a period of at
least 1 year before entering the study, and
the majority of the participants had tried
different treatment approaches for their hair
loss. The majority of the volunteers had
androgenic alopecia (56), while four had
alopecia totalis. All participants gave written
informed consent before entering the study.
A regional ethics committee approved the
study, which was conducted according to the
principles of the Declaration of Helsinki,
good clinical practice and local regulations.
STUDY DESIGN
The study was designed as a randomized,
placebo-controlled, double-blind study with
two arms. The subjects were randomized to
treatment either with Hairgain
®
or placebo
by a simple block-randomization procedure
(blocks of six). The duration of the blinded
phase was 6 months. The subjects receiving
active treatment in the blinded phase were,
thereafter, followed for another 6 months
in an open study on active treatment.
Participants receiving placebo in the blinded
phase were followed for an additional
12 months on active treatment. All subjects
were thus exposed to the active treatment for
12 months.
TREATMENT
Hairgain
®
and placebo capsules had the
same appearance and were packed in
similar plastic bottles in order to keep the
study blind. The dosage was two capsules per
day for subjects below 80 kg in body weight
and three capsules per day for those above
this weight, with one capsule to be taken in
the morning (together with food) and one or
two capsules to be taken in the evening. The
capsules were to be swallowed with 200 ml of
water on each occasion.
The Hairgain
®
treatment concept has
been developed by a Norwegian company
and contains minerals and vitamins in
addition to a marine protein extract from a
deep sea fish living along the Norwegian
coast line. Both the active and placebo
capsules were supplied by Med-Eq Ltd,
Tønsberg, Norway.
ASSESSMENTS
To ensure that hair-loss problems were
comparable in the two groups, a global
inspection of hair loss was performed at
baseline (day 0) and each volunteer’s hair
loss was graded according to internationally
accepted rating scales. The duration of hair
loss and previous treatment was recorded.
Participants came for a study visit every
second month during the blinded phase, and
every 6 months during the open part of the
study.
Overview photographs were taken, in a
standardized format, at the beginning and
4
E Thom
Treatment of hair loss
end of treatment. The overview photographs
were assessed (blind) by a suitably qualified
person not involved in the study. A special
method for taking standardized close-up
photographs was used initially and at each
study visit (Capilli Care; UPB Ltd, Nice,
France). On each occasion the same four
pre-defined areas of the scalp were
photographed and the pictures were
enlarged (× 80), allowing us to follow the
development of hair growth in given areas
by hair counting.
The subjects were also asked at each visit
to score their satisfaction with the treatment
on a 10-cm Visual Analogue Scale (VAS)
ranging from 0, not at all satisfied, to 10,
very satisfied. Participants also reported any
positive reports from close family members
or their hairdresser on hair growth.
Tolerability was checked on each visit by
asking the question: ‘Have you felt any
adverse effects that could be linked to the
treatment you have received?’ Compliance
was checked at each visit by counting
returned capsules. A requirement that at
least 80% of the recommended dose should
have been taken was used.
STATISTICAL ANALYSIS
SAS (version 6.0) software was used for all
statistical analyses. The two-tailed Wilcoxon
signed rank test was used to assess changes
compared with baseline. For significance
testing the 5% level was used.
Results
At baseline, the two groups were comparable
with respect to gender, age, duration of hair
loss, body weight, previous treatment and
number of subjects with alopecia totalis
(Table 1). The degree of hair loss was also
comparable in the two groups.
The assessment of the overview
photographs (blind) involved sorting the
photographs into probable treatment
groups; this procedure resulted in a highly
significant positive correlation with the
actual treatment groups, with more than
85% of the subjects in the active group
correctly classified (P < 0.01). Hair counting
based on the close-up pictures showed a
significant average increase in hair growth
of 32.4% in the blinded phase in the active
group, while the increase was negligible and
insignificant in the placebo group (Table 2).
A further improvement in hair growth took
place in the period between 6 and 12 months,
resulting in an average improvement in hair
growth of 63.9% at the end of the study. A
similar effect was seen in the group exposed
to placebo for 6 months initially, whose hair
growth improved by 60.8% after 12 months
of active treatment, a highly significant
improvement (P < 0.001) similar to that in
the group who started on active treatment.
The VAS scores for satisfaction in the two
groups during the blinded phase differed
considerably in the two treatment groups
Hairgain
®
Placebo
Sex (male/female) 28/2 27/3
Age (years) 37.8 (3.9)
a
38.6 (3.4)
a
Duration of hair loss (months) 18.6 (6.4)
a
20.4 (5.7)
a
Body weight (kg) 74.2 (11.1)
a
75.6 (10.6)
a
Previous treatment 15 (2.0)
a
13 (2.2)
a
No. of alopecia totalis cases 2 2
a
Means (± SD).
TABLE 1:
Baseline characteristics of volunteers with hair loss randomized to active treatment or placebo
5
E Thom
Treatment of hair loss
(Table 3). After 6 months the mean score of
the treated group was significantly higher
than that of the placebo group (P < 0.001).
There was a significant positive correlation
between the increase in hair growth as
measured by hair counting and the self-
evaluation by VAS score at the end of the
blinded phase (P < 0.001). The mean score of
the treated group after 12 months (open
phase) shows a further increase in
satisfaction. The results indicate that long-
term treatment (6 months or more) is
preferable in obtaining satisfactory results
with Hairgain
®
.
When the placebo group was switched to
active treatment, their VAS scores increased
from a mean (SD) of 0.9 (1.0) cm after
6 months of placebo to 6.2 (2.1) cm after
6 months of active treatment and 8.5 (2.4) cm
after 12 months of active treatment, progress
similar to that of the group who started with
the active treatment. The development in the
VAS score is highly significant (P < 0.001) after
6 months with a further improvement after
12 months’ exposure to the active treatment.
There was no response to either treatment
in the four patients with alopecia totalis. No
significant correlation was detected between
treatment result, age, gender or duration of
hair loss.
Several participants reported positive
responses from family and hairdressers
on their hair growth after having started
with Hairgain
®
. Several also reported a
pronounced improvement in nail and skin
quality after taking Hairgain
®
.
All the participants concluded the study
according to the protocol and none dropped
out due to side-effects of the study
medications. Tolerability was equally good
in the placebo and the active groups in the
double-blind phase. No serious side-effects
were reported in the open part of the study.
Discussion
The results show that subjects reported
favourable effects of active treatment on hair
gain compared with placebo, and this effect
was also seen in the open longer term study.
Duration of treatment VAS score (cm)
(months) Hairgain
®
Placebo
2 2.1 (1.9) 0.7 (1.3)
4 2.9 (2.1) 1.0 (1.5)
6 5.7 (2.6) 0.9 (1.0)
12 7.9 (2.5) –
Values are means (± SD).
TABLE 3:
Participants’ evaluations of their satisfaction with treatment on a Visual Analogue Scale (VAS)
Treatment duration Hairgain
®
Placebo
After 2 months 3.4 (3.1) 1.2 (3.6)
After 4 months 15.6 (3.2) 0.7 (3.1)
After 6 months* 32.4 (4.1) 0.9 (3.0)
*P < 0.001.
Values are means (± SD).
TABLE 2:
Average hair growth increase (%) based on hair counting in the two treatment groups during
the blinded phase
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E Thom
Treatment of hair loss
The present results indicate that long-term
treatment is needed to obtain significant
results. There was a positive correlation
between the subjects’ self-evaluations of
treatment effect and the objective counting
of hairs in the photos. The results obtained in
the present study compare favourably with
the results obtained in studies with drugs. In
a study with finasteride in 1533 men, the
increase in the number of hairs was reported
to be 11% compared with a 2.5% decrease in
the placebo group.
7,8
All of the participants used the active
preparation for 12 months, and we do not
know what will happen when the treatment is
stopped. It may be necessary to continue with
maintenance treatment at a lower dose.
The mechanism of action of Hairgain
®
is
not known, and future studies should
concentrate on this aspect. The positive effect
seen in this study together with the
excellent tolerability suggest that Hairgain
®
may provide a valuable alternative treatment
for those with androgenic alopecia.
References
1 Gjersvik PJ: Mannlig skallethet. Tidsskr Nor
Lægeforen 2000; 10: 1120.
2 Fyrand O: Det gåtefulle språket. Om hudens
kommunikasjon. Oslo: Universitetsforlaget,1996.
3 Mørk C: Hårtap. Årsak, diagnostikk, klinikk og
behandling. Tidsskr Nor Lægeforen 1997; 117:
3103 – 3106.
4 Barth JH: Should men still go bald gracefully?
Lancet 2000; 355: 161 – 162.
5 Cash TF: The psychosocial consequences of
androgenetic alopecia: a review of the research
literature. Br J Dermatol 1999; 141: 398 – 405.
6 Olsen EA, Weiner MS, Amara IA, DeLong ER:
Five year follow-up of men with androgenetic
alopecia treated with topical minoxidil. J Am
Acad Dermatol 1990; 22: 643 – 646.
7 Kaufman KD, Olsen EA, Whiting D, Savin R,
DeVillez R, Bergfeld W, et al: Finasteride in the
treatment of men with androgenetic alopecia.
J Am Acad Dermatol 1998; 39: 578 – 589.
8 Leyden J, Dunlap F, Miller B, Winters P,
Lebwohl M, Hecker D, et al: Finasteride in the
treatment of men with frontal male pattern
hair loss. J Am Acad Dermatol 1999; 40:
930 – 937.
• Received for publication 7 November 2000 • Accepted 14 November 2000
©2001 Cambridge Medical Publications
Address for correspondence
Dr E Thom
Postbox 210 2001, Lillestrøm, Norway.
E-mail: erling.thom@parexel.com
