Nisim Clinical Study
A Clinical Study on New Hair Biofactors
A.J. Farmilo, Ph.D.
M.A. Stratis, R.T.
H.L. Minuk, M.D. F.R.C.P.(C) A.B.I.M
One-hundred and forty-eight participants with varying
degrees of male pattern baldness (androgenic alopecia) participated
in an open-ended study using an all-natural compound solution to
determine the effects of hair regrowth.
The participants were photographed and initial hair
counts were done in a 2.5 cm diameter area of their balding scalp.
After five months of treatment, the participants were re-photographed
and hair counts were done on the same 2.5 cm diameter area of the
scalp. The results indicate that 85.7% of the men in the study had
an increase in their terminal hairs of 30% or greater. When evaluating
the percent increase more closely, we find that we can break the
date down into three separate groups:
- Significant regrowth
- Moderate regrowth
- No change
Showing significant regrowth was 40.8% of the study
group and had an increase of 100% or greater (doubling, tripling,
or more) of terminal hairs counted on their five month post-treatment
photo as compared to their initial pre-treatment photo. Of this
group, the highest increase of hairs was 472%, and the lowest increase
was 102% with the mean at 193.7% increase of hairs.
The group of men showing moderate regrowth, which
we classed as 30%-100% increase in terminal hair regrowth, was 44.9%
of the study group. The mean increase of that group was a 61.5%
increase of hair regrowth.
The remainder of the group, classed as no change,
was 14.3% of the study group, with an average of 6.7% increase in
Participants were told to use at least one bottle
per month (five bottles in five months) but were allowed to use
more if desired. We did not see any significant advantage to using
more than one bottle per month. Our conclusion is that the stimulatory
effect of the compound is achieved at the use rate of one bottle
The age range of the participants in the ability to
regrow hair was not a factor. The range of the participants in this
study was 24-68 years old, with the average age being 38.7 years.
In summary, this study concludes that the natural
herbal extract solution has a stimulatory effect on hair growth
for at least 8 out of 10 men with androgenic alopecia (balding).
The earlier stages of balding appear to respond to a higher degree,
but significant improvement was seen in participants at all stages
of baldness. There appears to be an optimum rate of use of the product,
and age does not seem to be a factor in response.
Hair performs no vital function relative to the medical
well-being of humans. Yet the psycho-social implications can never
be underestimated. Scalp hair can be the crowning glory for the
femininity of women and a potent symbol of masculinity and security
Reversal of male pattern baldness in men has for centuries
eluded science and medicine. Minoxidil (commonly known as Rogaine)
and Diazoxide have shown in past studies to reverse balding in men,
although in only small percentages of the patients studied.
This study demonstrated the safety and efficacy of
a natural compound solution to stimulate hair growth. The solution
is coupled with a treatment regimen which includes scalp cleansing
and proper scalp massAgeing.
Patients and Methods
One hundred and sixty four males with male pattern
baldness from the greater Toronto area were studied at the hair
clinic. After informed consent and observing past medical histories
and years of balding, the men were selected. Patients that were
using any form corticosteroids, cytotoxic agents, or any other form
of hair regrowth agent like minoxidil were excluded from the study.
It was decided to run an open-ended study. All men
were instructed and shown very carefully how to use the specially
formulated scalp cleanser and all natural compound solution. Once
this was handled, all the men were photographed with a high resolution
Minolta "instant pro" camera. The room was brightly illuminated
for close examination of the scalp and individual hairs. The camera
was positioned exactly 25 cm from the balding or thinning areas
with frontal, top, and rear pictures taken as needed. The participants
were asked to wait for the picture to develop and sign their respective
Administration and Dosage
The all natural compound solution was supplied at
no charge to the participants. Each person received 250 ml of the
alcohol based all natural compound solution along with 250 ml of
a specially formulated deep scalp cleanser. They were all individually
and carefully instructed on the proper usage of both the scalp cleanser
and the all natural compound solution.
Evaluation and Assessment Grading
The photos taken prior to the treatment were closely
evaluated. Before the treatment was initiated, a 2.5 cm circle in
diameter was drawn in the balding area, always very near the border
of the area demonstrating the most significant hair loss. Initial
hair counts were done using a 4X magnifying lens mounted on a circular
fluorescent lamp. Independent counts were made by two of us (MS
and AJF), times 2, and the average of the two counters was used
for statistical purposes. The hairs in the 2.5 cm area were counted,
including hairs on the circular boundary. The final counts on the
participants were done after five (5) months on the treatment program.
The same criteria from the initial photograph was used to determine
the exact location of the 2.5 cm area on the scalp and the same
procedure was used to count hair roots within and on the boundary
of the inscribed circular area.
At the conclusion of the five (5) month treatment
program, the photos were graded under the following categories:
A zero (0) grading was given to the photos that revealed no change
from their initial pre-treatment photo. A grading of one (1) was
given to the participants with moderate regrowth of hair from their
respective original photos. And a grading of two (2) was assigned
to the men with a significant regrowth of hair from their original
Of the one-hundred and sixty-four participants starting
the study, eleven were eliminated because of their repeated absence
from photo sessions and failure to use the product. Four were eliminated
due to their irregular use of both the scalp cleanser and the all
natural compound solution, and one person was discontinued because
he relocated to another country. The remainder of the 148 participants
applied the all natural compound solution at least twice daily for
the five months as required for this study.
The regrowth of hair was first noticed on some participants
as early as two months into the treatment. By the third month, a
substantial number of men demonstrated moderate regrowth; both fine
vellus hairs (peach fuzz) and darker pigmented intermediate and
terminal hairs were observed. It is noteworthy to mention that the
fine vellus hairs, although visible to the naked eye, were not detectable
by the photos. Thus all of our quantitative and qualitative assessments
were made from any intermediate and/or terminal hairs.
Criteria for Analysis of Response to All Natural
The following parameters were used to classify the
magnitude of hair regrowth: Subjects with less than a 30% increase
in intermediate and/or terminal hairs were counted as no change.
The moderate improvement group we determined were the men that showed
an increase of final hair counts of greater than 30% and up to a
100% increases of terminal hairs, in their five month photos as
compared to their original photos. The last group we identified
was the significant increase group. This group showed the best improvement
of all the men in the study, and we included those with hair count
increases of 100% or greater.
Response of the All Natural Compound Solution on
Although the qualitative and quantitative assessments
were done independently, there was a strong correlation between
the two groups. Overall, 88% of the qualitative group showed some
degree of improvement. Of the group studied quantitatively, 85.7%
showed a degree of regrowth (within 95% confidence limits). With
the qualitative group, 6 of 50 men were categorized as having no
change (category 0), representing 12% of the total. In the quantitative
group (98 participants), 14 men, or 14.3% did not show any increase
in hair counts. The average hair count increase for this group was
6.7%. So most subjects in this group did regrow some hair, but not
a noticeable amount.
The moderately improved qualitative group (category
1) consisted of 16 participants, or 32%. In the quantitatively studied
group, 44 of 98 men fell into the range of +30% to +100%. This represents
44.9% of the men. The range of increase was 32% to 98%, with the
mean at 61.5% The participants showing significant regrowth in the
qualitative group (category 2) were 28 of 50, or 56%. In the quantitatively
studied group, the number of men with significant regrowth (greater
than 100%) was 40 of 98, or 40.8%. These men had hair count increases
of 100% or more. The range of hair count increases was 102% to 472%,
with a mean increase of 194%. The photograph of these men and women
showed significant cosmetic changes which correlates very well with
our quantitative findings.
Pattern of Hair Regrowth
From the photos taken monthly during the course of
the study, a pattern of regrowth was observed in those participants
who demonstrated a significant increase in hair counts over the
five months. The first countable hairs were seen after 10-12 weeks
of treatment and were first detected on the crown or vertex of the
head. Following further treatment, hair was then observed regrowing
in the margin of fringe of the thinning or balding areas of the
scalp. Hair regrowth in the fronto-temporal region of the scalp
was noted after 16-20 weeks of treatment, and this region appeared
to be the most resistant to regrowth to date.
Correlation of Response with Age
The average age of the 176 participants was 38.7 years.
The mean ages for their respective groups were as follows: The no
change group was 41.8 years. The moderate group was 36.7 years.
And the significant group was 38.5 years. The youngest participant
in the study was 24 years old, and the oldest participant was 68.
There was no correlation between age and response to the treatment.
This open-ended study has demonstrated the hair regrowth
response of 148 men who have been treated with an all natural compound
solution applied topically to balding or thinning regions of the
scalp. The treatment program included regular scalp cleansing with
a natural extract scalp cleanser and application of at least 5-10
ml of the all natural compound solution at least twice daily. The
data showed that hair counts increased significantly for approximately
85% of the participants in the five month period.
The study methodology implies that the results obtained
relate not only to the all natural compound solution used in the
treatment, but also the overall treatment regimen. From previous
minoxidil (Rogaine) papers, it was determined by them that a reasonable
expectation for a "placebo-type" effect was a 10-15% increase in
hair counts. Thus, by setting the cut-off in this study for moderate
regrowth at a 30% increase, any increase due to a "placebo-type"
effect is discounted.
An attempt was made to correlate the response (either
no change, moderate change, or significant change) with a number
of factors. None of the factors studied gave a strong correlation,
although there were some trends noted. The number of years of balding
or thinning hair did not appear to have any correlation with the
final results. However, it should be noted that the number of years
thinning was a number given by the participants, and could not be
verified accurately. Thus it is a subject of assessment and may
not be very reliable. To help balance this uncertainty, the results
were grouped. Regardless of the groupings used, there was no grouping
which demonstrated a significant correlation with results.
In terms of hair regrowth, this all natural compound
solution appears to be more effective than minoxidil (Rogaine) and
has no known side effects. A study by Alanis showed that a 2% minoxidil
preparation applied topically increased hair counts by about 24%
after 20 weeks. This study showed an increase of 89% in the same
time period. Because of the differences in locating the measured
regions of the scalp, these results are not directly comparable,
but in a population study, Alanis's results showed that 34-46 out
of 83 participants (48%) had no growth after 24 weeks, whereas our
results show only 14 out of 98 (14%) had no growth after 20 weeks.
Thus, our conclusion is that this product does stimulate regrowth
of hair in cases of androgenic alopecia (balding), and that over
85% of men will respond favorably to the treatment.
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