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CG 210 hair loss lotion (Topicals & Shampoos)

posted by Habemus, Portugal, 27.09.2013, 15:14

2ª Part

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




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