Clinical Study on Nisim 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
Before - Photomicrograph of a scalp biopsy
demonstrating the immunohistochemical localization of DHT
(died red ) in the epidermal layer of the scalp.
After - Photomicrograph of the same scalp
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 data down into three separate groups:
1. Significant regrowth
2. Moderate regrowth
3. 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 regrowth.
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 per
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 in men.
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
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 photos.
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
* Criteria for Analysis of Response to All Natural Compound Solution
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 Baldness
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
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.