Nisim for hair loss
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A Clinical Study on New Hair Biofactors
Summary
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:
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 month.
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.
Introduction
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 scalp massaging.
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 photos.
* 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.
T
he 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.
Results
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 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.
Discussion
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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