Interview with American BioCosmetics LLC regarding the BX3.4 Helmet
HairLossFight.com has recently had the opportunity to
pose questions to Paul Gilbaud of American
BioCosmetics LLC, provider of the BX3.4 Hair Helmet in North America. Mr. Gilbaud was provided
with a set of questions which he in turn provided to the President of the Swiss company that
manufactures the helmet, Mr. Ivan Morgan, and the Chairman of the independent Scientific
Committee, Dr. Jean Guilbaud, MD, PhD. The answers to the questions were provided to me recently
via email and I am assuming the answers were a combined effort. I would like to thank Mr. Paul
Guilbaud, Dr. Jean Guilbaud, and Mr. Ivan Morgan for taking the time to answer these questions.
A note about this interview along with a disclaimer:
HairLossFight.com does not in any way make any claims with regard to the efficacy of the BX3.4
helmet in treating hair loss. We have not confirmed any of the claims that may be made by
American BioCosmetics LLC, or any of the people mentioned above, in this interview. We are merely
providing the text of the interview as is. Under no circumstances will HairLossFight.com be
held liable for any harm that may result from your use of this information, or misuse of this
information in any way. HairLossFight.com is completely independent from American BioCosmetics LLC,
and HairLossFight.com is not involved in the manufacture or distribution of it in any way.
HairLossFight.com will not be held liable for any harm that may result from the use of this product
to anyone in anyway. Nor will HairLossFight.com be held liable for any financial loss that may
result should you the reader or anyone else choose to purchase or use the product. Basically, we
are just conducting an interview, and the views and information provided by American BioCosmetics
may not necessarily reflect those of HairLossFight.com. HairLossFight.com does not know whether the
answers to the questions posed contain any claims that are not true or that break any laws. If
you don't agree with this disclaimer then please do not continue reading this interview. Should
you read this interview and take ANY FORM OF ACTION as a result of reading this interview, you do
so at your own risk.
Let us begin
the interview.
Interview with American BioCosmetics LLC
HairLossFight.com: How did the idea for the BX3.4 helmet come about, and how did you
proceed with its development?
American BioCosmetics: I'm still waiting for the president of BX3 General Labs in
Switzerland to respond to that precisely, but let me tell you what I know. An initial trial was
conducted using the oils that showed promising results but not good hearty hair growth. The
developer of the oils was introduced to a couple who had good results experimenting with pulsed
electromagnetic fields on hair growth, and they thought it a good idea to couple these together
for a clinical trial. They received a government grant from the French equivalent of the
National Institutes of Health (NIH), and contacted the top French dermatologists and pharmacists
from various universities to conduct a clinical trial, which is the one recently published.
Manufacturing was developed with engineering firms in Switzerland who follow strict ISO medical
device manufacturing standards, and the rest is history. I'll forward the president's answer to
you once I receive it.
HairLossFight.com:Please explain the rationale behind the helmet, along with what
forms of
hair loss the helmet has been shown to be effective in treating.
American BioCosmetics: In 1820, Oersted and then Arago discovered that any system
of electric current has the property of creating a magnetic field. Electromagnetic fields have
been used since in a variety of ways in the medical and cosmetic fields. Laboratory studies and
clinical findings indicate that a variety of cellular processes can be modified by electromagnetic
fields (EMFs), raising the possibility that EMFs might have broad therapeutic potential in a
number of diseases.
Twenty years ago, a review of the response of cells to EMFs had been conducted by Robinson K.R.
(Journal of cellular biology, 1985 ; 101 :2023-2027) who noticed that several cell types that
normally migrate or grow long distances in embryos respond directionally to surprinsingly small
fields and that developing embryos produce substantial endogenous currents. In Laboratories, the
in vitro responses to electromagnetic stimulation have been studied for a large variety of
cells :
-- fibroblasts, myocardial cells, nervous cells etc --
The laboratory studies have expanded knowledge of the mechanisms of pulsed electromagnetic
field (PEMF) action and shown that different pulses affect different biologic processes in
different ways. At the same time, numerous clinical studies have shown that high frequency pulsed
waves have a positive action on tissue regeneration and are efficacious in orthopaedics,
rheumatology, dermatology and in all the processes of wound healing in general as well as in the
inflammatory processes. To give an example, since 1973, electromagnetical methods have assumed an
increasing role in the clinical management of ununited fractures. The method was the first
electrical approach approved as safe and effective by the Food and Drug Administration in November
1979 ; in the following 6 years, more than 50 000 patients have been treated with PEMFs both in
the United States and abroad. The method is highly effective (more than 90% success) when used in
conjunction with good management techniques. It was also reported that when the skin lesions were
also present, their healing was enhanced by PEMF stimulation. Hence the numerous clinical reports
relative to the benefic effects of PEMFs on skin ulcers of arterial and venous origin.
In short, electrical stimulation of various types has been found to be an effective treatment
technique for accelerating the healing of both hard and soft tissue injuries. In 1997, after a
5-year review, the National Research Council concluded that environmental level, power frequency
EMFs do not pose human safety risks and this finding has reenergized interest in using EMFs for
therapeutic benefit.
All this data shows that the use of EMFs is justified each time a cellular repair process is
started. Concerning the hair field, a first study by Gunn C.L. and Lee M.H. (1980) reported an
experiment involving four men with early hair loss being treated with a commercially available
transcutaneous electrical neural stimulation device, resulting in a reduction of shedding, an
improvement in hair texture and a gradual resumption in growth rate. In 1988, in two open trials
involving 25 and 40 subjects, respectively, Bell P.W. reported that 84% of the former group and
70% of the latter showed regrowth after 60 days, utilizing the electrical modality being tested in
this study.
Considering that ... "the suggestion of electricity stimulating hair growth or regrowth had not
been properly investigated", Maddin W.S. in 1990 studied the biological effect of a pulsed
electrical field with specific reference to hair in a 36 week comparative, controlled study. The
treatment group exhibited a 66.1% hair count increase over baseline. Twenty nine of the 30 treated
subjects (96.7%) exhibited regrowth or no further hair loss.
The rationale of this phenomenon was considered to be due to an electrophysiologic effect on
the quiescent hair follicle, similar to that documented with respect to bone fracture and soft
tissue repair enhancement. Maddin theorized that the electrical pulse may cause increased cell
mitosis through calcium influx, involving both the hair follicle sheath and dermal papilla cells.
Then came BX3.4, whose main indication for the moment is the treatment of androgenetic
alopecia in both women and men -- or respectively ; hyperandrogenic female diffuse alopecia and
male pattern baldness (androgen-dependent alopecia) --.
HairLossFight.com:Do you have any clinical, scientific data regarding the efficacy
of the
helmet or the modality behind the helmet in the treatment of alopecia? If
so, can you provide this information?
American BioCosmetics:Yes, we do :
A preliminary study using the oils alone had demonstrated prevention of hair loss and
occasionally light growth. However, the isolated action of essential oils to regenerate hair
growth was not significant ; that's why we have conducted a second clinical study using a
combination of essential oils and electromagnetic pulses delivered by a helmet, whose goal was to
evaluate this original therapy for androgenetic alopecia in men and women. Simultaneously, a
histological study together with an immunohistochemical study have been performed from scalp
biopsies taken from the volunteers. This 6-months double blind, randomized, placebo controlled
study enrolled 69 healthy volunteers of both sexes (treated, n=40. control placebo n=29). Male
volunteers had stage I to stage VII alopecia as defined by the Hamilton-Norwood scale ; female
volunteers had stage I and II alopecia as defined by the Ludwig scale.
The results are very good : average hair count in the treated group increased from 152 h/cm2 on
day 0 to 174.8 h/cm2 at 3 months (+15%) and to 186 h/cm2 at 6 months (+ 23%) (P= 0.003), therefore
very significant. In the placebo group, average hair density did not change significantly (from
165 to 167 and to 174 respectively).
For the histological and the immunohisto-chemical studies, 60 biopsies have been performed, the
samples having been the same for both studies. The results show a good correlation between the
histologic examinations and the clinical study. Cellular index (Li%) was +80% after 3 months and
+77.3% after 6 months.
In summary, the results of this clinical study, reinforced and confirmed by those obtained from
a histological and immuno-histo-chemical study have demonstrated that the combination essential
oils + electromagnetic pulses not only prevents hair loss but also leads to a significant increase
in hair count after 6 months in masculine and feminine alopecia.
For more information, this data is published under the title :
"Essential oils and low intensity electromagnetic pulses in the treatment of
androgen-dependant alopecia"
Bureau J.P et Al in : Advances in Therapy, volume 20 No 4 July/August 2003, pp 220-229.
HairLossFight.com: Has the helmet been approved for use in treating hair loss by
the FDA,
or any other regulatory body in the world? Are you seeking FDA approval
for the helmet?
American BioCosmetics:The helmet has not yet been approved by the FDA as they
consider the combination of the helmet and oils a therapeutic treatment classed as a drug. The
number of patients and types of tests required to complete a full New Drug Application (NDA) as
well as the costs involved made it prohibitive for a small company like ouselves to prepare
clinical trials. We have therefore taken a different approach, and have decided to conduct
clinical trials using the helmet alone to demonstrate that the helmet is as effective as the
combination therapy at increasing hair count (if not on the hair quality and thickness). This
will allow us to complete a medical device submission which is less onerous and quicker, ending up
in a medical device approval for the treatment of androgenic alopecia and the prevention of hair
loss in men and women.
BX3.4 has been cleared in Europe (EU) and Switzerland as a Medical Device for the same
treatment, limited to androgenic alopecia as that specific pathology was the only one studied. It
is currently marketed in France, UK, Italy and Switzerland. Other countries are pending
registration.
We have already submitted a Pre-IDE to the FDA and have agreed on certain parameters for the
clinical trial, and intend submitting a Pre-Market Authorization or Pre-Market Notification in the
near future, or at least within the next year or so.
Meanwhile, the product is available, although no claims are made for its use, on the US
web-site :www.hair-loss-helmet.com.
HairLossFight.com: What is the highest level of hair loss, on the Norwood Scale,
that you
recommend using the helmet to treat, and what can be expected in terms of
results?
American BioCosmetics:A clinical study on the effects of the helmet in the
treatment of androgenetic alopecia has been performed by BX3.4. In this study, stage I to stage
VII alopecia as defined by the Hamilton-Norwood scale have been included. Everybody knows that
stages VI and VII are advanced stages of masculine androgenetic alopecia with little chance of
improvement. In spite of that, some of the volunteers with stage VI and VII alopecia have been
significantly improved by the treatment.
In 1985, De Villez R.L., from the Division of Dermatology, University of Texas Health Science
Center at San Antonio wrote in a medical Journal "Archives of Dermatology", that the patient
most likely to respond to treatment would be one who has been bald from less than 10 years and has
less than a 10 cm diameter bald area.
Things have evolved since, but he wanted to say that to have reasonable chances to recover all
lost hair, one knows that the lower the initial stage of alopecia, the better the results.
The helmet has all chances to be fully effective from stage I to stage V, and occasionally
effective in stages VI and VII. Only one requirement : to be sure that there are no underlying
diseases.
What can be expected in terms of results is set out in the clinical study by BX3: hair loss was
stopped in 96% of the cases ; 85% of volunteers presented an increase of their hair count > 10%
and 53 % of them an increase > 20% after only 6 months.
The best way to avoid the fact of having to treat a de facto situation, the longer the time
span the more difficult it is to treat, should be to start with the helmet as soon as one notice
an abnormally abundant and lasting hair loss, thus throwing in a prophylactic treatment.
HairLossFight.com:How does the helmet compare to the Hairmax lasercomb in terms of effectiveness in treating hair loss?
American BioCosmetics: To answer scientifically this question, the only way
should be to compare both treatments in a clinical study carried out according to the rules of
modern clinical studies. Through lack of a clinical study, we cannot express a value judgment. We
can however say something about the methodology used in their work:
One can be surprised, in reading the clinical report published in the International Journal of
Cosmetic Surgery, Vol 5., Number 2, 2003, concerning the hairmax lasercomb, to notice that the
number of studied patients is very limited, that the study is not a double blind randomized
placebo-controlled one, but a simple open study whose impact is shortened by the lack of
comparison with controls.
Moreover, the methodology used in this study is prone to criticism, not true to the classic
criteria, and a lot of important data is not available, like the stages of alopecia, or the
parameters at baseline.
One can be surprised also by the unusual results obtained, they seem almost too good to be
true; the lack of scientific data leaves a matter for serious perplexity and we prefer not to
answer this question.
HairLossFight.com: What can you say with regards to compliance with the use of the
helmet
and the topicals associated with it? In essence, how practical is it to
use effectively? I have always maintained the opinion on my site that the
simpler the regimen one uses in treating hair loss, the better. It would
appear at first glance that using the helmet consistently and regularly
can take some serious commitment and effort. Are the results that one can
obtain from using the helmet worth the effort?
American BioCosmetics: We share your opinion : the simpler the regimen, the
better.
But on one hand, the impact of hair loss on the sufferer is very important. Men and more
especially women consider their hair problems as a source of discomfort. Women describe themselves
as becoming less attractive and as a result, they restrict contacts in their private and social
lives. Consequently the impact is converted into several impacts -- impact on the social life,
impact on the occupational life, impact on the love life --.
In these conditions, it should be a pity not to assume all the care needed by such a state, as
restricting as it can be, especially when the treatment used is non invasive and particularly
devoid of adverse effects as is BX3. On the other hand, to assume 3 sessions per week with the
helmet is not so demanding for many reasons : the procedure is very easy to start up, it's not
time consuming because it can be included in the length of time one devotes to ones body care;
furthermore, during the session, you can do a lot of things such as reading, watching TV, talking,
writing or using a computer and so on/
In these conditions, it is not restricting to devote half an hour 3 times per week to this kind
of care considering the good results obtained with the oils and the helmet in the great majority
of the cases. Furthermore, the length of time devoted to the treatment itself is only 9 to 12
months, after which the number of weekly sessions is reduced to one, maximum two sessions.
HairLossFight.com: Do you have to use the helmet for life to maintain any results
that may
be obtained from its use?
American BioCosmetics:From the moment a biological process is started - the
inescapable deterioration and degeneration of a number of follicles - it's entirely justified to
act in order to put a brake on, and if possible to check this process to maintain the results
obtained. Consequently, it is perfectly natural to carry on with a treatment which has proven its
effectiveness. Nevertheless, the rhythm of hair care can be relaxed, and the number of helmet
sessions can be reduced to one, maximum two per week, depending on the context. In conclusion,
one would need to continue "for life" if one wished to maintain the results obtained.
HairLossFight.com: How long does it take to get cosmetically significant results?
American BioCosmetics:To make precise reference to this question, the
cosmetically significant results are obtained after the 3rd month of treatment, the term cosmetic
results being here understood in the literal meaning.
To get significant results in terms of hair count -- which in turn acts on the cosmetic aspect --
needs 6 months, even if good results are noted as soon as the third month.
HairLossFight.com: Do you have any before and after pictures that you can share
with
HairLossFight.com?
American BioCosmetics: We do have an array of pictures from the clinical trial,
where patients were followed on a regular basis and pictures were taken at day 0, and six months.
We are attempting to collate pictures from our distributors around the globe who may also have
pictures sent in by satisfied customers and users. We will forward these to you as soon as
possible. Meanwhile, some pictures are available on a number of web sites, such as www.hair-loss-helmet.com, www.bx3-4.com, www.assured4hairloss.co.uk.
HairLossFight.com: Would you say that the helmet should be used by everyone? Or is
there a
particular criteria that should be used in determining whether the helmet
will work for a hair loss sufferer?
American BioCosmetics:Everyone may use it in view of its perfect innocuousness
and total lack of side effects. The specific absorption rate (SAR) is 0,002 W/Kg, well under the
recommended limits set by the United States Federal Communications Council (FCC) of 1,6 W/Kg for
cellular telephones. So even a child could theoretically use it, assuming that the right
indication is respected, that is: androgenetic alopecia.
But it is important to eliminate other hair pathologies, or hair disorders, and especially for
women certain systemic or general pathologies reponsible for hair loss like : ovarian polycystosis
or low serum ferritine levels which provide an estimate of the iron stores. The importance of
adequate serum ferritin levels in the treatment of diffuse androgen-dependent alopecia has been
evidenced by Rushton: without adequate levels hair regrowth is prevented (serum ferritin
concentrations above 40mg/mL appear essential. Similarly, vitamin abuse can be a cause of hair
loss.
HairLossFight.com: Thank you for time and your answers.
The following URL will take you to the website for American BioCosmetics LLC:
American BioCosmetics LLC
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