A Clinical Study on New Hair Biofactors
Performed by:
A.J. Farmilo, Ph.D.
M.A. Stratis, R.T.
H.L. Minuk, M.D. F.R.C.P.(C) A.B.I.M
Published in the Medical Post Vol. 29 pg 61 August 24,
1993
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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 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
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.
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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.
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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.
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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.
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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. |
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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.
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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.
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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.
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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.
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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.
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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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figure 3 |
figure 4 |
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Figure 3
- Photomicrograph of a scalp biopsy
demonstrating the immunohistochemical localization of
DHT (dyed red) in the epidermal layer of the scalp.
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Figure 4
- Photomicrograph of the same scalp after
treatment. |
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