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-- WITH PHOTO -- TO BUSINESS, HEALTH, AND MEDICAL EDITORS:
PuraCapT Pharmaceutical Reports Key Involvement in Trial of a
Ceramide-Dominant Emulsion for the Prevention of Atopic Dermatitis in
Newborns
SOUTH PLAINFIELD, N.J., Feb. 27, 2014 /PRNewswire/ -- PuraCapT
Pharmaceutical today announced its supportive participation in the
"Prevention of Eczema by a Barrier Equilibrium Strategy" Trial
conducted under the sponsorship of the Murdoch Children's Research
Institute and in collaboration with the University of Melbourne and
The Royal Women's Hospital in Melbourne, Australia. The study, known
as the PEBBLES Trial, is designed to assess the twice-daily use of
EpiCeram@ Controlled Release Skin Barrier Emulsion, a
ceramide-dominant complete lipid mixture, as a strategy to prevent the
development of eczema in infants at increased risk for developing
allergic conditions.
(Photo: http://photos.prnewswire.com/prnh/20140227/PH72993 )
It is now recognized that skin barrier function plays a critical role
in the development of eczema. Since infants have a poorer skin barrier
function than adults, it is possible that defects in barrier function
in early life results in increased risk of eczema. The PEBBLES study
intends to evaluate this hypothesis with daily intervention of
EpiCeram to replenish and improve skin barrier function, thereby
reducing the incidence of this very common and painful skin disease.
EpiCeram clinical efficacy and physician experiences will be showcased
at two upcoming national scientific meetings: The 2014 American
Academy of Allergy Asthma and Immunology on February 28-March 4 in San
Diego (Exhibit Booth #108); and the 2014 American Academy of
Dermatology on March 21-25 in Denver (Exhibit Booth #1754).
According to specialists, precluding the development of eczema and its
first cousin atopic dermatitis may be the first step in the prevention
of the "Atopic March," a documented progression of allergic disease
manifested first by eczema, followed by food allergy, allergic
rhinitis and asthma.
"We have designed this Phase II trial to provide the data necessary to
validate that a novel lipid-rich replenishing agent can restore skin
barrier function in newborns, and thereby prevent the onset of eczema
and progression to other allergic diseases," said Dr. Adrian J. Lowe,
PhD, Murdoch Childrens Research Institute, Parkville, Australia, and
lead investigator of the PEBBLES Study. "We are grateful to PuraCap
for supplying EpiCeram for this clinical study."
About the PEBBLES Trial
In the current randomized controlled trial, 100 infants with a
first-degree history of allergic disease (eczema, asthma or food
allergy) will be recruited. The clinical outcome assessor will be
blinded to whether subjects receive product or are in the control
group. Evaluations of skin barrier function will take place at 6
weeks, 6 months and 12 months of age. Primary endpoints are the
incidence of eczema and allergic sensitization at 6 and 12 months,
along with skin barrier function at 6 weeks and 6 months.
The PEBBLES Trial follows an Australian pilot study of 10 at-risk
infants from birth to four weeks of age who underwent application of
EpiCeram to the full skin surface, excluding hands and face, during a
six- week intervention period. Researchers concluded that clinical
results support the safety and parental compliance with daily
application of this novel approach for the prevention of eczema.
"PuraCap is pleased to provide EpiCeram for this important clinical
trial that will further our understanding of atopic dermatitis and
potentially influence the incidence of this prevalent childhood
disease," said Elise Klein, VP of Brand Marketing for PuraCap
Pharmaceutical. "We are optimistic that early interventions to
improve skin barrier will also help reduce the risk of asthma,
allergic rhinitis and food sensitivities that impair the quality of
life for young children and their families." The PEBBLES study is
funded by the Financial Markets for Children and the Asthma Foundation
of Victoria.
EpiCeram Controlled Skin Barrier Emulsion is a controlled-release,
prescription product that helps to relieve the burning and itching
associated with skin conditions such as atopic dermatitis/eczema. It
is the only topical agent formulated with three essential lipids
(ceramides, free fatty acids, and cholesterol) in a physiologically
balanced ratio, which mimics the lipid concentration found in the
skin. A steroid-free topical formulation, EpiCeram is FDA-cleared for
the treatment of eczema.
About PuraCapT Pharmaceutical LLC
PuraCapT Pharmaceutical LLC is an emerging, fully integrated
pharmaceutical company with expertise in product development,
manufacturing and bringing affordable, world-class quality products to
their customers. The PuraCapT corporate structure supports their
three-prong approach for global growth with dedicated companies in the
areas of prescription brands, PuraCapT Pharmaceutical LLC;
prescription generics, PuraCapT Laboratories Inc.; and OTC and Private
Label products, PuraVationT Pharmaceuticals Inc. For more information
on PuraCapT Pharmaceutical LLC, visit the company's website at
Contact: Elise Klein 908.941.5456, Ext 640; Email
Or
Nadine Tosk for PuraCap/EpiCeram 504.453.8344; Email
Read more news from PuraCap Pharmaceutical LLC.
SOURCE PuraCap Pharmaceutical LLC
-0- 02/27/2014
/Photo: http://photos.prnewswire.com/prnh/20140227/PH72993
PRN Photo Desk, photodesk@prnewswire.com
/Web Site: http://www.puracap.com
CO: PuraCap Pharmaceutical LLC
ST: New Jersey
IN: HEA MTC PHA
PRN
-- PH72993 --
0000 02/27/2014 13:30:00 EDT http://www.prnewswire.com
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