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Hair Prime For Both Men and Women
DOUBLE BLIND HAIR GROWTH
STUDY - THE EFFECTS OF HAIRPRIMEŽ
These are the
results of the latest independent, clinical, double-blind
study conducted by Dr. Joseph Greenberg, a Board Certified
Dermatologist and Clinical Professor of Dermatology at
U.C.S.F. This study was presented at the Annual Conference
of the American Academy of Dermatology (Feb. 1995), and
Published in the prestigious Journal of Dermatological
Treatment (Sept. 1996), and the
Townsend Letter (Nov. 1996).
The study shows that
HairPrimeŽ helped to promote thicker, healthier hair growth
for 90% of the subjects in the active group. Accompanying
photographs may be viewed here. Full text with tables and
graphs will be faxed or mailed upon request.
Average Percentage Change
Between HairPrimeŽ & Placebo Groups
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TABLE 1
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Average % Change
HairPrimeŽ Group
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Average % Change
Placebo Group
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| Total
Hair Count |
77.4 %
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0 %
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| Terminal
Hair Count |
169 %
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35 %
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Introduction:
Twenty-four healthy male
subjects with Stage III-IV androgenetic alopecia were
enrolled in a randomized, double-blind, parallel
vehicle-controlled study to confirm the effectiveness and
safety of a topically applied, standardized 7.5% herbal
preparation (HairPrimeŽ) cream used once daily in the
treatment of androgenetic alopecia--the most common cause of
hair loss, affecting one third of both men and women.
In preliminary studies
HairPrimeŽ produced encouraging results as a hair growth
agent. In one pilot study, all 18 subjects showed increased
hair counts, averaging 119%. The investigator observed a
very high percentage (50-100%) of conversion from vellus to
terminal hair, and hair remelanization (50-100%).
HairPrimeŽ cream has also
been evaluated for the treatment of scalp seborrhea and
psoriasis. The results of this study confirm the safety and
effectiveness of the cream formulation and should be of
interest to both general practitioners and dermatologists
who treat patients with androgenetic alopecia.
Materials
and Method
Study design and medications:
HairPrimeŽ is a patented,
standardized 7.5% herbal extract in a cream base vehicle.
The extract is standardized by replicative methods,
including standardization against specific compounds which
appear naturally in the extract.
A double-blind,
placebo-controlled trial was conducted to compare the effect
of HairPrimeŽ on hair growth in males with androgenetic
alopecia against its placebo vehicle. The subjects were
given either HairPrimeŽ or a placebo of vehicle only. Both
the active and the placebo groups were each randomly
assigned four subjects with excessive hair loss. Patients
applied the cream to the scalp daily, at approximately 24
hour intervals, for 40 weeks and were seen in the clinic for
efficacy and evaluation every 4 weeks throughout the study.
Subjects had their hair collected six times at eight week
intervals (eight weeks at baseline and an additional forty
weeks of follow-up).
Twenty-four healthy male
subjects under the age of 55 were selected for the study.
The average age of the participants in the active group was
45.6 years versus 40.3 years for the placebo group. All
subjects had Stage III-IV androgenetic alopecia. Eight
subjects had excessive hair loss. The initial evaluation
included health history, physical exam and evaluation of the
alopecia condition. Any subjects with underlying diseases or
subjects using systemic drugs (e.g. steroids, anti-hypertensives,
cytotoxic compounds, vasodilators, anti-convulsant drugs,
beta blockers, spironolactone, cimetidine, cyclosporine,
anti-depressants) were excluded from the study. Informed
consent was obtained from all patients before study entry.
Each subject was tattooed with a permanent ink on their
vertex area, creating a one centimeter triangle. The hair in
the triangle was collected and the subjects entered an 8
week baseline period evaluation before beginning treatment.
During the study (including
the baseline period of eight weeks) all the subjects washed
their hair daily with HairPrimeŽ Shampoo. This was done to
avoid the variable that the use of different shampoos would
introduce.
Assessment Procedures:
Two of the
commonly used methods of evaluating hair growth are: (1)
counting the hair on the scalp in a marked area and (2)
various photographic techniques. Both methods can have a
large margin of error due to the difficulty in counting hair
on the scalp and the possibility of photographing a bent
hair shaft and counting it as two hairs. To avoid these
problems a more accurate method for evaluating hair growth,
based on a protocol developed by Price, was employed. The
evaluation included: total hair count and terminal (non-vellus,
melanized, mature) hair count.
Each subject was
tattooed with permanent ink at three points on their vertex
area creating a one centimeter triangle. After rinsing the
hair at the permanent site with water and soap, the hair was
washed with acetone to remove any debris that could change
its weight. The hair from the triangle was collected using
great care to harvest only within the marked area.
The hair
collected was placed on white paper, counted and then
divided into terminal hair (non-vellus, melanized, mature
hair) and vellus hair. The terminal (non-vellus, melanized,
mature) hairs were then counted.
Results:
Efficacy results
demonstrate that HairPrimeŽ cream, used once daily, is much
more effective than the placebo cream vehicle in the
treatment of androgenetic alopecia. Table I compares the
average percentage change from baseline of the total hair
count and terminal (non-vellus) hair count between the
HairPrimeŽ and the placebo-treated groups.
After 40 weeks,
70% of the subjects in the active group had greater than a
30% increase in total hair count, compared with 16% of the
subjects in the placebo group. The average total hair count
for HairPrimeŽ treated subjects increased by approximately
75%, compared to a 0% increase for the placebo treated
subjects. 90% of the subjects in the active group had
greater than a 30% increase in terminal (non-vellus,
melanized, mature hair) hair counts, compared with 33% of
the subjects in the placebo group. The average terminal hair
(non-vellous, melanized, mature hair) count for HairPrimeŽ
treated subjects increased by approximately170% over the
same period, as compared to an approximately 34% increase
for the placebo treated group.
Adverse
Effects
No local
irritation, sensitization or other averse effects were
observed or reported in either the active or placebo groups.
CONCLUSION:
HairPrimeŽ
cream, a 7.5% standardized herbal extract preparation, is
safe and effective in the treatment of androgenetic
alopecia.
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