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I guess TBT needs the traffic or something. He's been banned every where else except one other place that I can tell..and I think he's pretty new there...
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ive heard of the man with no name now its the man with delution of hair regrowth.Comment
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Read this study, please
A randomized, double-blind, and placebo-controlled 12-month efficacy study of CG 210 on hair diameter in male alopecia subjects already using Finasteride 1 mg
A Takeda1, S Harti2, J Liu2, L Zhang3 and A Sato4 1School of Medicine, Kitasato University, Kanagawa, Japan; 2Legacy Healthcare, Lausanne, Switzerland; 3Legacy Healthcare, Lausanne, Switzerland and 4Tokyo Memorial Clinic, Tokyo, Japan
Study rationale: Finesteride is often regarded as first-line treatment for male patients with androgenic alopecia (AGA). However, after several years of treatment, patients often reach a plateau.
CG210 is a GMP-grade topical botanical blend that has clinically demonstrated its efficacy to reestablish regular A/T ratio (and hence normal hair cycle) in AGA sufferers within 44 days. Its unique clinically validated mechanisms of action are: preventing premature apoptosis of cells in hair follicles; reducing micro-inflammation in the scalp, and increasing collagen content. We would expect to get a beneficial effect when combining oral Finasteride 1 mg (acting on androgens) with topical CG210 (acting on apoptosis and micro-inflammation, two key factors causing hair loss).
Hair diameter is an accurate clinical parameter for hair miniaturization (larger diameter=longer anagen phase=improved proportion of anagen vs telogen hair (A/T ratio)). An increase in hair diameter should also affect the cosmetic appearance and hair volume.
Objective: To evaluate the clinical effect of the topical anti-hair loss CG210 vs placebo on hair diameter in Japanese AGA patients already using Finasteride 1 mg for >3 years.
Study design: Randomized, double-blind, placebo-controlled, single-center, prospective, with two parallel groups.
Group A: Topical placebo provided to nine male alopecia subjects already taking Finasteride 1 mg treatment for >3 years.
Group B: Topical CG210 provided to seven male alopecia subjects already taking Finasteride 1 mg treatment for >3 years.
Results: Mean diameter of hair in the Finesteride+topical CG210 group versus Finesteride+placebo group increased by 36.9%. No adverse events were observed.
Conclusion: Application of topical CG210 in combination with Finasteride 1 mg demonstrated a statistically and clinically significant improvement in hair diameter and overall cosmetic appearance. Therefore, CG210 offers AGA sufferers an effective option to be used either alone to prevent and stop excessive hair loss or in combination with Finasteride to enhance patient outcome.
Att,Comment
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CG210 Enables Finasteride 1mg Users to Further Improve Hair Pattern: A
Randomized, Double-Blind, Placebo-Controlled Pilot Study
Akira Takeda1,2, Akio Sato2,3, Lei Zhang4, Saad Harti4, Geert Cauwenbergh4 and JiaWei Liu4,5*
1Department of Plastic and Aesthetic Surgery, Kitasato University School of Medicine, Sagamihara, Kanagawa 252-0374, Japan
2Department of Regenerative Medicine Plastic and Reconstructive Surgery, Kitasato University School of
Medicine, Sagamihara, Kanagawa 252-0374, Japan
3Tokyo Memorial Clinic, Tokyo 151-0053, Japan
4Legacy Healthcare, Route de la Corniche 9B, 1066 Epalinges, Switzerland
5Teaching staff, PPCR course, Harvard Medical School, USA
Abstract
Background: The efficacy of Finasteride 1mg, the first-line treatment for male Androgenetic Alopecia (AGA), tends
to reach a plateau after several years’ treatment. Up to date, effective and safe options are limited because current
modalities managing AGA have so far not taken into account the two key issues particularly relevant to excessive hair
loss: the early onset of catagen (due to premature hair follicular cell apoptosis) and the frequently observed sustained
micro-inflammation in the scalp.
Objective: We investigated the potential synergic effect of combining the oral finasteride 1mg, acting on conversion
of testosterone to 5α-dihydrotestosterone, with CG210, a novel topical anti-hair loss product, acting on premature
apoptosis and micro-inflammation in the scalp.
Methods: We designed a 12-month, randomized, double-blind, placebo-controlled trial using CG210 in twenty
AGA volunteers already using Finasteride 1mg for at least three years. Hair diameters were assessed and compared
for hair pattern improvement.
Results: The increase of hair diameter in the “Finasteride 1 mg + topical CG210” group was 37.7% more than that
in “Finasteride 1 mg + topical placebo” group (p=0.002). No side effect was observed.
Conclusion: In addition to 5α-reductase inhibitors, our study puts forward the approach to simultaneously
address both premature cell apoptosis in the hair follicles and micro-inflammation in the scalp. The results suggest an
efficient mode in the management of AGA with improved efficacy over the currently referenced modality. Furthermore,
the studied topical CG210 may represent a new option for alopecia subjects, including those under finasteride 1mg,
to improve their hair pattern.
*Corresponding author: JiaWei Liu, Teaching staff, PPCR course, Harvard
Medical School, Legacy Healthcare, Route de la Corniche 9B, 1066
Epalinges, Switzerland, Tel: +41 78 8849782; Fax: +41 21 6534484; E-mail:
j.liu@legacyhealthcare.ch
Received June 24, 2013; Accepted August 01, 2013; Published August 03, 2013
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
Copyright: © 2013 Takeda A, et al. This is an open-access article distributed under
the terms of the Creative Commons Attribution License, which permits unrestricted
use, distribution, and reproduction in any medium, provided the original author and
source are credited.
Keywords: Androgenetic Alopecia (AGA); Apoptosis; Microinflammation;
Hair diameter
Introduction
Hair growth contains four phases: growing anagen (A), regressive
catagen (C), resting telogen (T) and latent kenogen, during which
the hair follicle remains empty after hair shedding. Alopecia sufferers
commonly enter catagen phase prematurely and persist latent phase
for a variable duration. Hence, kenogen and particularly the onset of
catagen are important parameters for understanding the consequences
of changes in the hair growth cycle [1]. Normally, over 80% of the
hairs are in their anagen phase and less than 20% in telogen and
catagen phase, corresponding to an A/T ratio above 4. Conditions of
Androgenetic Alopecia (AGA) cause premature onset of the catagen
phase where hair follicle cells, such as matrix cells and cells linking
hair to dermal papilla, massively go through apoptosis. Thus, hair
shedding is accelerated over time because the cyclical growth pattern of
the hair is repeatedly interrupted by this apoptosis-driven Premature
Onset of Catagen (POOC), leading anagen phase to end too early,
before reaching its maximum thickness (diameter), ending up with
miniaturized hairs and ultimately balding [1-3]. Phototrichogram is
based on the determination of hair cycle duration and A/T ratio; hence
such a hair loss disorder can be denoted by an A/T ratio inferior to
4 [4-6]. In addition to Phototrichogram and histological studies, hair
diameter measurement [7] is recognized to be one of the main and
utmost appropriate methods to assess progressive miniaturization of
hair follicles (smaller hair diameter), as well as AGA treatment efficacy.
Apoptosis during catagen development correlated with a downregulation
of the anti-apoptotic protein Bcl-2 [3,8,9]. Bcl-2 level was
shown to be decreased by androgens, especially dihydrotestosterone
(DHT) in dermal papilla cells [10]. Furthermore, in vitro and in vivo
studies demonstrated that down-regulation of apoptosis in human
scalp hair follicles could stimulate hair growth [6,11].
Androgen/DHT not only decreases Bcl-2 level, but also stimulates
synthesis of transforming growth factor-beta2 (TGF-β2). TGF-β2 then
up-regulates synthesis of caspases (such as caspase 9) and triggers
intrinsic caspase network leading to excessive apoptosis of matrix
cells in hair follicles and therefore early onset of catagen [12]. Such an
‘‘intrinsic apoptosis pathway” is principally mitochondrial dependent
and executed by members of Bcl-2 protein family [13-18]. Hence, in
order to re-establish normal hair cycle, it is essential to restore the
anti-apoptotic Bcl-2 level in the scalp of AGA subjects. A former study
showed that topical application of the new hair lotion CG210 (a GMPCitation:
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 2 of 5
Hair Ther Transplant Volume 3 • Issue 1 • 1000107
ISSN: 2167-0951 HTT, an open access journal
grade topical botanical blend from Legacy Healthcare, Switzerland)
could bring irregular hair cycle at the time of inclusion (where the
average A/T ratio was 2.96) back to its normal pattern in 44 days
(where average A/T ratio returned to 4.30) (p<0.05, data realized by the
Dermatological Institute of Aquitaine, Martillac, France). The followup
mechanistic investigation [19] via Immunohistochemical analysis
of AGA biopsies revealed that the topical CG210 not only prevented
premature apoptosis (by almost reestablishing the normal level of Bcl-
2) but also attenuates the micro-inflammatory status in the scalp (by
acting through Langerhans cells), two key aspects causing AGA [20-
23].
Finasteride 1 mg selectively inhibitstype II 5α-reductase that
converts testosterone into more androgenic DHT. Although Finasteride
is regarded as the first line treatment for male androgenic alopecia,
patients tend to reach a plateau after several years’ treatment [24]. The
trend in hair lotion development is to focus on criteria suggested by the
clinical practice guidelines for AGA. However, up to date, effective and
safe therapies are limited [25-27] because current treatment protocols
have so far not taken into consideration key issues highly relevant to
excessive hair loss, i.e. micro-inflammatory status in the scalp and
premature apoptosis that leads to early onset of catagen [20,28]. Based
on the afore mentioned observation, we designed a randomized,
double-blind, placebo-controlled efficacy pilot study to investigate
the potential synergic effect when combining oral finasteride 1 mg
treatment (acting on androgen conversion) with CG210 (acting on
follicular cell apoptosis and scalp micro-inflammation), aiming to
evaluate hair diameter improvement following topical application of
CG210 in AGA subjects already using Finasteride 1mg for at least three
years.
Subjects, Materials and Methods
Subjects
After approval by the internal review board ethical committee,
the study was carried out at Tokyo Memorial Clinic (Japan) between
March 2011 and April 2013.Twenty healthy male volunteers between
31 and 67 years old, suffering from AGA corresponding to the stages
ranging from IIv to IV of the Hamilton classification gave their
informed consent to participate in the investigation. All patients had
been already using Finasteride 1mg for more than three years. Their
demographic characteristics are given in (Table 1).
Test substance
CG210, a GMP grade, topical botanical blend provided by Legacy
Healthcare, Switzerland.
Study design
Randomized, double-blind, placebo-controlled, single centre,
prospective trial with two parallel groups for the study of the potential
synergic effect by combination of oral Finasteride with topical CG210.
Subjects in both Group A and Group B had been taking Finasteride
1mg treatment for at least 3 years and continued to take Finasteride
1mg during the whole study period. A computer algorithm previously
determined randomly whether the volunteer received CG210 or
placebo. After giving informed consent, volunteers were provided
with consecutively numbered supplies of study topical lotion – either
CG210 or identical-appearing placebo. This process resulted in 10 AGA
volunteers receiving the topical placebo (Group A), 10 AGA volunteers
receiving the topical CG210 (Group B). All subjects applied the topical
lotion once a day, in the evening before going to bed, with a total dose
between 1.3 to 2 ml.
All volunteers were instructed to report any symptoms suggesting
side effect related to topical application of the lotion.
Clinical scoring and photographs
A dozen of hairs at the parietal region midline part were collected
and cut at the bottom end 1cm. The hair samples were then measured
using the Keyence Corporation IM6020 device. One important aspect
of this assessing method is to be able to capture both the minimum
range and the maximum range of hair diameter. As the cross section
of a hair is oval, the minimum range was chosen for the statistical
analysis. The average hair diameter was scored in micrometer (μm).
The procedure is summarized in (Figure 1, a-d).
In order to avoid drop-out due to the long duration of the study,
volunteers were asked to complete follow-up visits at four time points
(0, 3, 6, 12 months). Measurements of hair diameters at the time of
inclusion (0 month, baseline value) were compared with hair diameters
at the end of the study (12th month). Meanwhile, photographs of “0
month” and “12-month” were also compared using a Nikon COOLPIX
P6000 camera.
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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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 5 of 5
Hair Ther Transplant Volume 3 • Issue 1 • 1000107
ISSN: 2167-0951 HTT, an open access journal
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Att, habemusComment
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Where r the pictures...others than habsComment
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More photos? You guys give me time to have growth, phew! ...
Att,
Comment
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Looks even worse now.Comment
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wow the second pic has one more hair and in black colour ...
thats regrowth.....
like 0.00000001%
congrats...Comment
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Yes the existing hairs have definitely grown longer. You may stop using it once you are satisfied with the lengthComment
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^lol!Comment
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Wow, that are the same freaking pics you posted 6 months ago!!!!Comment
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boys,
Take it easy. Some will need glasses to view a regrowth, understand ...
7 months passed and soon I will bring news, ok? lol
Att,
Comment
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Ok old man.Comment
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friends,
Soon I will put new pictures of progress with this lotion.
In December I will change treatment and inform which product will include.
greetings,Comment
Comment