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Clinical Study on Viviscal Formulas
The Journal of International Medical
Research 1992; 20: 445 - 453
A
Comparative Study of a New Food Supplement, ViviScal®, with Fish Extract for the
Treatment of Hereditary Androgenic Alopecia in Young Males
A. LASSUS AND E. ESKELINEN
Department for Dermatological
Research, ARS-Medicina, Helsinki, Finland
A controlled, randomized,
double-blind, parallel-group study compared the effects of Viviscal® (a new food
supplement incorporating special marine extracts and a silica compound) with
those of a fish extract in the treatment of young males with hereditary
androgenic alopecia. The pretreatment histological diagnosis was alopecia with a
mild to moderate perifollicular inflammation zone. The study consisted of 20
subjects who received two tablets of Viviscal® once daily and 20 who received
two tablets of fish extract once daily for 6 months. The mean patient age and
mean duration and severity of baldness compared well between the two groups.
Most patients had been treated with long-term topical 2% minoxidil for 1 year or
more prior to the study. At baseline and after 6 months' treatment, a biopsy was
taken for histological examination. A non-vellus hair count was performed at
baseline and after 2, 4 and 6 months. In the fish extract treatment group three
patients withdrew from the study before the fourth month due to lack of
therapeutic effect. After 6 months' treatment, patients receiving Viviscal®
showed a mean increase in non-vellus hair of 38% compared with a 2% increase in
the fish extract treatment group (P<0.0001). In the Viviscal group, 19 (95%)
subjects showed both clinical and histological cure, whereas none treated with
fish extract showed any clinical or histological difference after 6 months'
treatment (P <0.0001). In both groups, a minimal decrease in the erythemal index
was observed. In conclusion, Viviscal® appears to be the first highly active
treatment for androgenic alopecia in young males.
INTRODUCTION
Basic
amino acids, fats and vitamins are essential for the growth of healthy hair.
Undernourishment slows the growth rate of hair and extreme starvation may render
people totally bald. In some animals, such as rats and mice, all hair appears to
be in the same state of activity and all cyclic changes are synchronized(1),
whereas in humans the cycle of each follicle occurs independently from that of
the adjacent ones, thus exhibiting a mosaic pattern. Hair cycles are divided
into three stages: anagen, a growing or active phase; catagen, a regressive
stage; and telogen, a resting stage(2-4). The relative duration of
these phases varies with the individual's age, nutritional status and hormonal
influences.
Hair growth is regulated by
several factors(2-4) and the roles of innervation and vascularization
have not been fully elucidated. Sex hormones play an important role in the
growth, distribution and pigmentation of human hair. The varying effects of
circulating androgens and the different types of human hair in various locations
have led to the hypothesis that there are differences in the metabolism of
hormones in follicular tissue. The conversion of testosterone to the more active
dihydrotestosterone (DHT) in certain target cells depends upon the presence of
the enzyme 5alpha -reductase(5,6). The DHT combines with a cytosol
receptor to form a complex that enters the nucleus and joins with chromatin to
initiate protein synthesis. The metabolism of androgens can be impaired either
by decreased conversion of testosterone to DHT or by an inability of cells to
accumulate DHT because of the absence of the cytosol receptor protein. The
primary catabolic product of androgen metabolism in both growing and resting
hair follicles is androstenedione(7) . The conversion of testosterone
to androstenedione via 17beta hydroxysteroid dehydrogenase present in the cell
occurs at 10 times the rate of the 5alpha- reductase system that yields DHT. The
effects of androgens on sexual hair growth and scalp hair loss could be mediated
through changes in intracellular concentrations of cyclic adenosine
monophosphate.
In terms of structure, there are
three types of hair: vellus; terminal; and intermediate. Vellus hairs are short,
fine, soft, usually non-pigmented and unmedullated, whereas terminal hairs are
large, heavily pigmented and medullated, and intermediate hairs occur on the
scalp and demonstrate a morphology between those of terminal and vellus hairs,
i.e. they are medullated and contain a moderate amount of pigment. The balding
process involves conversion of the follicles such that they produce vellus hairs
rather than terminal hairs(8).
Of the 100 000 - 150 000 scalp
hairs on a human adult, 90% are in the growing or anagen phase, which lasts for
4 - 8 years. The remaining 10% are in the resting or telogen phase, which lasts
for about 100 days. About 50 - 100 clubbed hairs are shed each day and this
occurs regardless of sex, although there is considerable variability between
individuals.
Throughout history men have
concocted various potions from animal, vegetable and mineral substances in an
attempt to improve hair growth and at the present time hair transplants and
scalp reductions are used to minimize visible alopecia. A hair transplant
involves removal of hair from the back of the head and transplantation to the
bald area. The large follicles removed from the back of the head remain normal
in size after transplantation and continue to produce long, large hairs in the
new area. Scalp reduction involves excision of the bald area and drawing
together the remaining skin. This procedure can be combined with the management
of skin flaps, whereby parts of the hairy scalp are surgically moved to the bald
area. The results of such surgical procedures, however, are not always
cosmetically acceptable.
The alternative approach is the
use of pharmaceutical preparations. Minoxidil, a piperidinopyrimidine
derivative, is a potent peripheral vasodilator. Recent trials using topical
minoxidil have shown that it has a stimulatory effect on hair regrowth in some
individuals with either androgenic alopecia or alopecia areata(9-12).
Several reports have recently demonstrated that certain proteins derived from
marine fish have a stimulatory effect on hair growth in females(13-15).
It was, therefore, of interest to develop a new compound containing a special
mixture of an extract of marine origin with a silica compound and compare it
with a fish extract that contains the same type of proteins. The study was
carried out in a double-blind fashion for 6 months in young healthy males with
androgenic alopecia.
PATIENTS AND METHODS
Patients
A total of 40 males with androgenic
alopecia classified on the Hamilton scale(16) as III - V took part in
the study. The patients were divided randomly into two groups, 20 in each (Table
1), and one group received two tablets of Viviscal® for 6 months and the other
group two tablets of fish extract for the same period of time. The two groups
compared well with regard to demography (Table 1) and clinical baldness, and all
were aged between 20 and 30 years. The duration of hair loss suffered by the
volunteers varied between 2 and 9 years, and most of them had received prior
treatments, most commonly 2% minoxidil solution. All subjects were in good
health and gave oral informed consent before the start of the study.
STUDY
DESIGN
Clinical
visits were scheduled bimonthly for 6 months and non-vellus hair counts were
performed at baseline and at each clinical visit, with an individual template
used for each patient. A template with a 2.5-cm diameter hole was centred over
the posterior vertex and non-vellus hairs within the hole were counted with the
aid of magnification and bright illumination.
A punch biopsy specimen (5 mm)
was obtained from the centre of the bald scalp both at baseline and after 6
months. The punch biopsy was subsequently used to locate the target area for
hair counts.
At the start of the study and at
each subsequent visit, an erythemal index meter (Diastron Ltd, UK) was used to
measure the erythemal index(17) at the centre of the bald area. In
addition, patients were questioned about their observations regarding hair loss.
STATISTICAL ANALYSIS
Statistical
methods were applied to continuous as well as categorical data collected during
the study. Categorical variables were analysed with a standard X2-test
for homogeneity and Fisher's exact test was also used. Results were declared
statistically significant if the corresponding P-value was less than 0.05 and
marginally significant if the P-value was greater than or equal to 0.05, but
less than or equal to 0.10.
RESULTS
Of
the 40 patients randomized, 37 were evaluable after 6 months: 20 in the Viviscal®
treatment group and 17 in the fish extract group. All three patients in the fish
extract group who withdraw from further treatment before the 4-month assessment
of progress did so because of lack of efficacy or increased hair loss.
In the Viviscal® treatment group
all patients reported that there was no hair loss after 2 months' treatment,
whereas in the fish extract group hair loss continued during the entire
treatment period.
There was significantly more
regrowth of non-vellus hair throughout the treatment period in the Viviscal®-treated
patients compared with those treated with fish extract (Table 2). Comparison of
baseline bald area and after 6 months' treatment showed a marked improvement.
The mean number of new non-vellus hairs was 472 (mean increase 38.1%) in the
Viviscal® treatment group and 26 (mean increase 2.1%) in the fish extract group;
this difference was highly statistically significant (P<0.0001). Patients'
estimates of new hair growth were similar to those of the investigators. A
non-significant decrease of the erythemal index was observed in both groups.
The histological examination at
baseline showed typical alopecia in all 40 patients, with mild to moderate
perifollicular inflammation. After 6 months, alopecia could no longer be
diagnosed in 19 of the 20 patients in the Viviscal®-treated group. The remaining
patient in the Viviscal® treatment group (a 29-year old male) still had typical
alopecia and moderate perifollicular inflammation and showed no increase in non-vellus
hair. He had had androgenic alopecia for 9 years and, during that time, had been
topically treated with 2% minoxidil for 18 months, with 20% tretinoin solution
for 8 months and, additionally, had undergone two hair transplants, both of
which failed.
All 17 patients in the fish
extract treatment group who completed the 6 months' course still had
histologically verified alopecia with persistent perifollicular inflammation.
No adverse reactions were
observed by the investigators or were reported by the patients in either group.
DISCUSSION
In
the present study, Viviscal® proved to be highly effective in the treatment of
androgenic alopecia of short duration in young males, with 19 of the 20 patients
being completely cured as shown by non-vellus hair count and histological
examination. The only treatment failure occurred in a subject who had the
longest duration of alopecia in this group. This subject had severe
psychological problems associated with his condition and had attempted suicide.
He had earlier tried a variety of treatments including topical minoxidil and
tretinoin as well as hair transplants, but without success. This patient may not
be suitable for treatment with such preparations as Viviscal®, and possibly no
treatment would be effective for this subject.
The mechanism by which Viviscal®
works has not been elucidated, although in the present study the treatment has
been shown to be highly effective. Previous studies have indicated that oral
treatment with Vivida®, a fish protein extract, resulted in improved hair growth
in women being treated for photo-aged skin(13-15). The silica
compound component of Viviscal® may also be important and it is probable that
several nutritional factors have a synergistic
effect and improve the
efficacy of the compound.
There was a decrease, although
not significant, in the erythemal index indicating that the mechanism of
Viviscal® may not depend on vasodilatation, which has been speculated to be an
important factor regarding the mechanism of action of topical minoxidil.
In conclusion, Viviscal®seems to
be effective in the treatment of androgenic alopecia in young males. The present
study also suggests that the cartilaginous fish extract, which affects the
condition and growth of hair in females, does not affect androgenic hair loss in
young males. A further two studies in older males with a longer period of
androgenic hair loss are in progress.
REFERENCES
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L, Happonen HP, et al: Imedeen® for the treatment of degenerated skin in
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Patterned loss of hair in man: types and incidence. Ann NY Acad Sci 1951; 53:
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A. Lassus and A.
Eskelinen
A Comparative Study of a
New Food Supplement, ViviScal®, with Fish Extract for the Treatment of
Hereditary Androgenic Alopecia in Young Males
The Journal of
International Medical Research 1992; 20: 445 - 453
Received for publication
20 August 1992
Accepted 26 August 1992
Copyright 1992 Cambridge
Medical Publications
Address for
correspondence
Dr A. Lassus
Department of
Dermatological Research, ARS-Medicina, Stora Robertsgatan 8 A 1, SF-00120
Helsinki, Finland
Viviscal® is the
registered trade name of Vivida Europe BV, Holland.
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