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ViraDerm
The Herpes Virus
Clinical Studies
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ViraDerm
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The Herpes Simplex Virus
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ViraDERM,
by Empire Pharmaceutical Inc., is a patented, nonprescription topical
preparation marketed for the treatment of herpes-induced cold sores. Its
ingredients, stannous fluoride and glycerin, are "Generally Recognized as Safe
and Effective" (GRASE) for application to the oral cavity by the U.S.
Food and Drug Administration. The subject of an FDA-granted "Investigational New
Drug Application" (IND), VIRADERM was tested in a controlled clinical trial
where it outperformed placebo by its ability to shorten healing time and prevent
new lesions from forming. Rigorous in vitro testing by a prestigious
virology laboratory showed that VIRADERM may be directly virucidal and unlikely
to induce drug resistance. Intriguing accounts from practitioners and patients
who have used VIRADERM for herpes infections other than cold
sores, have lead to clinical investigations
for these conditions. |


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Herpes is a virus that causes non-curable
infections with symptoms ranging from embarrassing to painful and debilitating.
The term "herpes" derives from an ancient Greek word meaning, "to creep, or
crawl". Three types of infections are caused by the virus: the Herpes simplex
virus (HSV-1) gives rise to cold sores around the mouth and nose; virtually the
same virus, called Herpes simplex-2 (HSV-2), causes Genital Herpes; and the
Herpes zoster Varicells virus (HZV) is responsible for Chickenpox and shingles.
Viruses injure tissue when they reproduce, or replicate, commandeering
the reproductive machinery of the host cell. Each form of herpes
replicates in the same way.
The infections
are not curable, sometimes hiding for years in the body’s nerve cells (facial
nerve cells-HSV-1, near the spinal column-HSV-2) as a dormant or latent ailment
when not active. "Outbreaks" are stimulated by factors such as stress, reactions
to drugs, intense sunlight, fever or trauma.
HSV-1 and HSV-2
are contagious, passing from one person to another-the first by kissing and the
latter by sexual contact. HZV, while not communicable as shingles, is
transmitted as Chickenpox.
Physicians and healthcare professionals diagnose
and treat both Genital Herpes-HSV II and Shingles-HZV. |
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Genital herpes is
a sexually transmitted disease (STD).
Present as rupturing blisters in its most virulent phase, it is highly
contagious, often painful, and may be accompanied by flu-like symptoms. The
disease causes difficulty in sexual relations and frequently leads to
psychological distress. Those infected typically suffer four or five outbreaks
a year. The sores take between 2 to 4 weeks to heal. The disease causes
complications in pregnancy and potentially fatal infections in babies.
Shingles is the most painful , and possibly the
most disfiguring of the herpes diseases.
The HZV infection results in a widespread rash, replete with blisters and
crusting, often appearing on the face. The pain can be so severe that it may be
mistaken for pleurisy, kidney stones, gallstones, appendicitis, or even a heart
attack, depending on the location of the affected nerve. High dose prescription
oral antiviral agents are the treatment of choice, though they serve only to
shorten the course of an episode--provided therapy is started within 48 hours of
the first symptoms. Other than steroids and other external analgesics to
alleviate symptoms, there is no topical treatment for shingles.
Herpes Simplex-1 (cold sores)
is a self- treatable condition,
therefore less likely to be seen by clinicians. From the first sign of an
outbreak – a tingling on the lip – to full bloom with a very red, somewhat
painful and often ulcerative nodule, the outbreak usually lasts 7-10 days. Many
times, sufferers don’t even get to doctors until the disease has passed its peak
– with nothing left to resolve the infection but time. The topical antiviral
medicines are only marginally effective--shortening healing times by no more
than 12 hours. They remain available by prescription solely for their
propensity to elicit viral resistance, a public health concern. |
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ViraDerm is a product with documented
activity against HSV-1. It relieves symptoms and cuts lesion resolution
time without requiring a prescription or physician office visit. The product
is remarkably safe with a long, successful history of use among millions of
patients and decades of use in the dental care category. ViraDerm employs a
patent protected formulation of stannous fluoride that appears to prevent
viral attachment, stopping the herpes virus from penetrating the cell in the
first place. With the virus no longer able to replicate, cold sore
outbreaks are minimized and healing time reduced. By applying
ViraDerm at the "prodromal" or the pre-cold sore tingling phase of a herpes
outbreak, many users have reported no lesions at all.
ViraDerm has been sold in Florida under the
aegis of the Florida Department of Health. |
A clinical trial
performed to FDA guidelines confirmed the effectiveness of ViraDerm against
HSV-1. It showed both fewer and less
severe cold sore lesions, and anticipated outbreaks that did not occur.
Large scale trials are underway to
support new, stronger claims and indications than currently approved.
ViraDerm offers additional therapeutic
potential than its standard OTC drug designation, FEVER BLISTER/COLD SORE
TREATMENT, may imply. Recent
scientific evidence suggests that ViraDerm attacks the herpes virus
directly, adding an outright curative property to its benefit of symptomatic
relief. By virtue of its unique ionic properties, ViraDerm appears to
prevent the herpes virus from penetrating the host cell, thus (arresting)
breaking the organism’s natural cycle at its most destructive stage, long
before tissue damage takes place. Moreover, ViraDerm’s putative mechanism
of action would seem to apply to all three strains of herpes simplex: HSV-1,
HSV-2, and HZV.
For this reason
ViraDerm is being made available exclusively to Department of Defense
practitioners interested in participating in open-label studies of ViraDerm
in the three common herpetic conditions: Cold Sores, Genital Herpes, and
Shingles. The product – ViraDerm – is available exclusively
to Department of Defense personnel as a viable treatment for HSV-1
infections (cold sores) worldwide. This limited availability is offered
while the product is further tested for new claims and indications.
To order ViraDerm please fill out the
enclosed order form. For additional
information, please email your request to:
info@usamediainc.com.
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