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CG 210 hair loss lotion (Topicals & Shampoos)

posted by Habemus, Portugal, 27.09.2013, 15:16

3ª Part

Data management and statistical analysis
Descriptive and inferential analyses were performed with STATA
Statistical Softwareversion11.0 (Stata Corp College Station, TX). Hair
diameter variables from “Finasteride + CG210” and “Finasteride +
Hamilton
classification at
inclusion
No. of patients
(N=20)
Median history of
finasteride use and
Range (month)
Median age of
patients and Range
(year)
IIv 2 39 (30-48) 39.5 (31-48)
III 2 49.5 (45-54) 42.5 (42-43)
IIIa 2 47 (43-51) 43 (36-50)
IIIv 7 44 (36-108) 43 (32-54)
IV 7 47 (36-67) 45 (37-55)
Table 1: Demographic characteristic of the volunteers. Age, History of Finasteride
use and Hamilton classification of patients are described.
Figure 1: Graphic illustrations for hair cutting and measurement.
a: Schematic design showing cutting area on parietal region.
b: Image showing the way how to cut hair for measurement.
c: IM6020 device (Keyence Corporation) used to measure both the minimum
and the maximum range of hair diameter of the collected hair samples.
d: Image showing hair measurement.
a. cutting area on parietal region b. cutting hair
c. IM6020 (Keyence Corporation) d. measurement
Citation: Takeda A, Sato A, Zhang L, Harti S, Cauwenbergh G, et al. (2013) CG210 Enables Finasteride 1mg Users to Further Improve Hair Pattern:
A Randomized, Double-Blind, Placebo-Controlled Pilot Study. Hair Ther Transplant 3: 107. doi:10.4172/2167-0951.1000107
Page 3 of 5
Hair Ther Transplant Volume 3 • Issue 1 • 1000107
ISSN: 2167-0951 HTT, an open access journal
Placebo” groups at two time points (0 and 12 months) were assessed
using analysis of covariance adjusted for the baseline diameter of each
participant. A two sided p-value <0.05 was considered to be statistically
significant.
Results
Hair diameter as clinical scoring
Hair follicle miniaturization is the key point during development
of androgenic alopecia. Therefore, hair diameter represents an easy,
reliable and accurate clinical measurement to characterize hair
follicle miniaturization and its improvement following anti-hair loss
treatment.
After 12 months topical application of the botanical blend
CG210, the product was well accepted by the subjects and there was
no complaint for inconvenient use of CG210. In Group A, an average
increase of 2.12 μm in hair diameter was observed, which corresponded
to + 4.17% differences. However, in Group B, the average increase of
hair diameter was 2.98μm, representing an augmentation of + 5.74%.
In terms of “between group” difference, the outcome from Group
A (oral Finasteride 1mg + topical placebo) differed significantly from
that of Group B (oral Finasteride 1 mg + topical CG210)(p=0.002).
Compared to Group A, an additional 37.7% increase in hair diameter
was observed in Group B. The results are summarized in Table 2.
Case study
A 43 years old Japanese man used Finasteride 1mg for 3 years and
started the application of topical botanical blend CG210 for 12 month
in combination with oral Finasteride 1mg. The “before” and “after”
photographic documentation is shown in Figure 2.
Adverse events
The topical solution CG210 can be easily applied on the scalp and
was well accepted by the volunteers. The safety evaluation of adverse
reactions was conducted via interviews in all men enrolled during the
entire study. No adverse events associated with the long-term product
use were observed during the 12-month trial duration.
Discussion
Considering that hair follicle miniaturization is the key point
during androgenic alopecia onset and development, hair diameter
represents one of the most important features to be considered as an
accurate clinical sign reflecting the status of hair follicle miniaturization.
Therefore hair diameter, which can be easily recorded as clinical
scoring, is an accessible and reliable parameter that should be taken
into consideration for further characterization of hair loss disorders
and for evaluation of the outcome following treatment.
Finasteride 1mg treatment alone has proved a varying degree of
success in many long-term users because it acts as a 5α-reductase
inhibitor that blocks the formation of dihydrotestosterone (DHT), one
of the important factors causing excessive hair loss. Nevertheless, its
positive effect may reach a plateau indicating that the strategy to simply
deal with hormonal issue cannot guarantee sufficient amelioration in
AGA patients as observed in the placebo-controlled group of this trial,
as well as in several other studies. Indeed, the development of AGA
requires the interaction of both genetic and hormonal factors, as well
as many other defined or not-yet-defined factors [29-34]. Nevertheless,
whatever factors it might be, due to internal and external insults,
the hair loss process is very often accompanied with chronic microinflammation
in the scalp and the hair follicle cells will inevitably
undergo premature apoptosis, which is particularly associated with
follicle regression (catagen) [13,35]. Early apoptosis of cells in the hair
follicle provokes Premature Onset of Catagen (POOC) that precedes
excessive hair loss in men and women. As a consequence of such an
apoptosis-driven POOC, anagen phase ends and catagen phase onsets
“ahead of time”. For that reason, instead of growing to its maximum
diameter, hairs become progressively miniaturized vellus. The topical
CG210, being an agent that can positively modulate against premature
apoptosis (early onset of catagen) and dampen uncontrolled scalp
micro-inflammation, is therefore geared to address specifically these
two crucial aspects (micro-inflammation and premature apoptosis)
that largely contribute to excessive hair loss.
Each day we shed on average less than 100 hairs. Naturally, an
equivalent number of new hairs grow out to replace the lost hairs
and keep the total number of hair steady. The rate of hair loss will
increase dramatically when hair follicles are subjected to all sorts of
internal and external stress. In particular, the genetically predisposed
hair follicles are the target for androgen-stimulated hair follicle
miniaturization, leading to barely visible, depigmented vellus hairs
[36]. Indeed, the DHT-mediated inflammation reduces significantly
Group Number of
Participants
Mean
age of
subjects
Mean hair
diameter
(microns)
Mean hair diameter
change after 12
months
Inclusion 12
months
Difference
(microns)
Difference
(%)
Placebo +
Finasteride
(Group A)
10 43.8 50.88 53.00 2.12 4.17%
CG210 +
Finasteride
(Group B)
10 44.1 51.93 54.91 2.98 5.74%
Group
difference* 37.72%
*p = 0.002
Table 2: Comparison of hair diameter increase in Group A (oral Finasteride 1 mg +
topical placebo) and Group B (oral Finasteride 1 mg + topical CG210). The average
age of patients and the mean values of hair diameters (microns) at conclusion and
the end of the trial, as well as the final changes of hair diameters (in percentage)
are summarized in this table (n=20). Hair diameter variables from Groups A and
B at the time of inclusion and at the end of the study (12th month) were compared
using analysis of covariance model (two sided) with adjustment of baseline hair
diameter for each participant. Note that in terms of “between group” difference,
the outcome from Group A differed significantly from that of Group B (p=0.002).
Compared to Group A, an additional 37.7% increase in hair diameter was observed
in Group B.
Figure 2: Case study: the pictures of a 43 years old Japanese volunteer,
showing comparison of “before” (left picture, hair diameter measurement:
47.1 ± 3.92μm) and “after” twelve months’ combined use of oral Finasteride
1mg and the topical CG210 (right picture, hair diameter measurement: 51.9
± 10.8μm).
Citation: Takeda A, Sato A, Zhang L, Harti S, Cauwenbergh G, et al. (2013) CG210 Enables Finasteride 1mg Users to Further Improve Hair Pattern:
A Randomized, Double-Blind, Placebo-Controlled Pilot Study. Hair Ther Transplant 3: 107. doi:10.4172/2167-0951.1000107
Page 4 of 5
Hair Ther Transplant Volume 3 • Issue 1 • 1000107
ISSN: 2167-0951 HTT, an open access journal
the blood flow to the scalp (2.6 times lower than that of healthy people)
[37], consequently damaging and depriving hair follicles of blood and
nutrients. On the other hand, excessive apoptosis (cell debris) will
stimulate the production of pro-inflammatory
mediators by monocyte/
macrophages [38-40] triggering or aggravating inflammatory
status. Hence, the premature apoptosis and the micro-inflammatory
conditions will not only cause early onset of catagen and the “silencing”
of hair regrowth, but also impede the restart of a new hair cycle. As
mentioned before, the direct benefit following topical application of
CG210 turned out to be a rapid normalization of A/T ratio, signifying
new growth of more anagen hairs. Normalized anagen phase will surely
allow the hair, including the new anagen hair to grow uninterruptedly
to a larger diameter, finally contributing to the overall higher hair
density.Therefore, by addressing at the same time the issues of early
apoptosis, scalp micro-inflammation and hormone (DHT), CG210 and
Finasteride 1mg are able to produce a synergic effect in AGA subjects
who had no more significant improvement by using Finasteride 1mg
alone.
An average of additional increase of almost 38% in diameter for
each hair stands for a significant synergic effect. However, in order
to fully confirm the scale of such a beneficial effect thanks to the
finasteride-CG210 association, one may want to increase the testing
power by proceeding with further studies using a much larger sample
size as so to overcome the limit of this study and finally determine the
“effect size” owing to finasteride-CG210 combination.
On the other hand, the long-term repeated use of the topical
botanical blend CG210 in this 12-month clinical study showed
reassuring safety profile that is consistent with the previous studies.
One of the earlier studies showed that Bcl-2 over expression inhibited
cell death and promoted morphogenesis, but not tumorogenesis [41].
Likewise, normalization of Bcl-2 level by CG210 in AGA volunteers
provided with a survival advantage to the cells under hostile AGA
conditions but without promoting uncontrolled cell proliferation.
As a conclusion, and in agreement with what was discussed
previously in terms of the complex etiology of AGA [21], we propose
that the new standard in the management of excessive hair loss
should also address the two key issues that currently have not yet
been simultaneously tackled, i.e. premature cell apoptosis in the hair
follicles and micro-inflammation in the scalp. The clinical features
of the novel topical botanical blend CG210 constitute a safe and new
relevant strategy to help the alopecia subjects, including those already
using Finasteride 1mg, improve substantially the hair loss conditions
and the cosmetic volume of hair, so as to alleviate excessive hair lossrelated
distress.
Acknowledgments
The authors thank Dr. Jessica Paulus (Tufts University), Dr. Roger Davis
(Harvard School of Public Health) and Dr. Felipe Fregni (Harvard Medical School)
for their valuable comments and suggestions regarding the data management of
this study.
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A Randomized, Double-Blind, Placebo-Controlled Pilot Study. Hair Ther Transplant 3: 107. doi:10.4172/2167-0951.1000107
Page 5 of 5
Hair Ther Transplant Volume 3 • Issue 1 • 1000107
ISSN: 2167-0951 HTT, an open access journal
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