The following articles/news releases are about a new
drug called Protopic Ointment. Protopic ointment, an immunomodulator,
is currently indicated for the treatment of moderate to severe eczema
(atopic dermatitis). Currently, an investigator initiated study is
underway with support from Fujisawa Pharmaceuticals of Japan, to
evaluate the safety and efficacy of Protopic in the treatment of
Vitiligo. Topical immunomodulators alter (down-regulate) the immune
response in the skin. Protopic ointment may be useful in curbing the
immune response against pigment cells in the area of Vitiligo.
Currently, however, those with Vitiligo should be aware that the
Protopic label does not mention "Vitiligo" specifically, and the Food
and Drug Administration regulatory requirements do not support the
clinical investigation or use of Protopic at this time. We are hopeful
that study results will eventually lead to such an approval.
For more information about Protopic as it relates to Vitiligo, please
read our new Vitiligo FAQ page (Frequently Asked Questions).
Vitiligo & Pigmentation Institute of Southern
Eczema Ointment Shows Promise for Vitiligo Sufferers
LOS ANGELES, Feb 22, 2002 /PRNewswire via COMTEX/
Protopic, the first in a new class of drugs called
topical immunomodulators (TIMs) shows promise as an innovative
treatment option for Americans with Vitiligo, a difficult skin
condition characterized by stark white patches of skin throughout
sufferers' bodies caused by a mysterious loss of pigmentation.
"We achieved success with Protopic in restoring pigment to affected
areas in 100 percent of patients tested," said Pearl Grimes, M.D.,
Chair of the Vitiligo & Pigmentation Institute of Southern California
and lead investigator of the study presented at the 60th Annual
Meeting of the American Academy of Dermatology in New Orleans. "This
is an early sample of the database we now have of patients treated
with Protopic for Vitiligo. We have experience with more than 150
patients and we have the utmost certainty that Protopic assumes a
place in the hierarchy of treatments for vitiligo for children and
The poster presentation included results with six patients ranging
from 7 to 38 years of age. Patients applied tacrolimus ointment to
affected areas of their bodies twice daily for a period of one to five
months. Various degrees of repigmentation were achieved in all
patients, with one patient experiencing excellent repigmentation (100
percent) four patients experiencing moderate repigmentation (50-75
percent) and one patient experiencing mild repigmentation (25-50
Vitiligo can affect anyone, but the condition is more obvious on
people with darker skin. Light skinned people usually notice the
contrast between areas of Vitiligo and suntanned skin. Overall,
Vitiligo affects one or two out of every 100 people. Commonly affected
parts of the body include the face, hands, arms, legs and genital
areas. Vitiligo is not associated with any other physical health
problems, although many people with the distressing condition are
afflicted with low self-esteem, depression, job discrimination and
other psychological disorders related to their appearance. Although
doctors do not know what specifically causes Vitiligo, research
indicates that genetics might be a factor.
Protopic (tacrolimus ointment) was approved by the FDA in December
2000 for the treatment of moderate to severe eczema. Tacrolimus is
part of a new class of drugs called topical immunomodulators, or TIMs,
and was the first new class of treatments for eczema approved by the
FDA in more than 40 years. Protopic's safety and effectiveness was
based on 28 worldwide clinical studies of more than 4,000 adults and
children (as young as 24 months of age) suffering from moderate to
FDA Approves Protopic (Tacrolimus) Non-Steroidal
Ointment For Eczema
DEERFIELD, IL -- December 11, 2000 -- A new
option is on the way for the 15 million Americans who currently suffer
from the painfully itchy skin disorder atopic dermatitis, more
commonly known as eczema.
Fujisawa Healthcare, Inc., announced today that the U.S. Food and Drug
Administration (FDA) has approved Protopic® (tacrolimus), a
non-steroidal topical ointment, for the treatment of the signs and
symptoms of moderate to severe eczema.
The 0.1% concentration of tacrolimus ointment was approved for the
treatment of adults and the lower 0.03% concentration was designated
for the treatment of both children (ages two and above) and adults for
short-term and intermittent long-term therapy.
Protopic is the first in a new class of drugs called topical
immunomodulators, or TIMs, to be developed in more than 40 years for
the treatment of eczema. The approval of this steroid-free option
offers significant hope for those experiencing the devastating
physical and emotional effects of atopic dermatitis. Protopic is also
being tested for use in treating Vitiligo and other skin disorders.
"Today's FDA approval of Protopic marks a milestone for eczema
sufferers and treating physicians," says Dr. Amy Paller, Professor of
Dermatology and Pediatrics and Chief of Medical School in Chicago,
Illinois. "As a pediatric dermatologist I see first- hand both the
physical and emotional difficulties young eczema sufferers experience.
The approval of Protopic finally gives prescribing physicians an
effective, non-steroidal option for treating the often painful and
frustrating symptoms resulting from eczema."
Protopic's safety and effectiveness was based on 28 worldwide clinical
studies of more than 4,000 adults and children (as young as 24 months
of age) suffering from moderate to severe eczema. The studies were
conducted in the United States, Europe and Japan. Over one-third of
the patients were children.
The study data reported that both concentrations of Protopic
significantly improved or cleared the signs and symptoms of the
condition in more than 2/3 of the patients. In fact, many patients
showed marked improvement in just one week of treatment.
Conventional therapies for eczema have been limited and variable
outcomes have been reported. Routine treatment frequently includes the
use of steroid creams applied to the skin. Steroids have been
associated with side effects including: skin thinning, stretch marks
and skin discoloration. Physician and patient satisfaction has been
disappointing. Protopic offers physicians another treatment option
when conventional treatment is deemed inadvisable because of the
potential risks associated with them, or when patients are not
adequately responsive to or intolerant of conventional therapies.
Similar to other dermatological products currently on the market,
Fujisawa advises that patients practice safe sun techniques to avoid
direct exposure to natural or artificial sunlight. Some patients
reported skin burning and itching associated with the application of
Protopic however, the incidences of these events decreased as the
Eczema is a chronic, life-altering disease characterized by painfully
red, swollen, itchy, flaky skin. In some cases the itching and redness
is so vast and intense that sufferers will scratch themselves until
they bleed, increasing the risk of secondary infection. The majority
of eczema cases are diagnosed in early childhood. While 40 percent of
children suffering from eczema outgrow the disease, others live with
it throughout their lives.
Since 1970 the prevalence of atopic dermatitis has nearly tripled.
Studies show that the steady increase of this chronic condition is
generally attributed to irritants and allergens that trigger the
immune system. Emotional factors such as stress can also influence and
worsen the condition.
In addition to the physical symptoms, atopic dermatitis also
diminishes the quality of life of patients and their families. For
sufferers, especially teenagers, the visibility of eczema flares can
lead to low self-esteem and often the inability to interact with
others. Recent survey data from the National Eczema Association for
Science and Education states that 56 percent of respondents feel
embarrassed or self-conscious in public during a flare and 80 percent
experience disrupted sleep. Atopic dermatitis sufferers and their
families also say that leisure activities in their daily lives, such
as playing sports or taking family vacations, are also disrupted.
To address the emotional effects of eczema, Fujisawa Healthcare
conducted Quality of Life Studies as part of their clinical trials
that were presented in March 2000 at the 58th meeting of the American
Academy of Dermatology (AAD). Patients, parents or guardians involved
in the 12-week medical study completed a survey that scored the
physical and emotional improvement of the patient and family in
question. "Our Quality of Life (QOL) assessment found that eczema
sufferers treated with Protopic had significant improvements in sleep,
symptoms, everyday activities and feelings," says Dr. Lynn A. Drake,
Massachusetts General Hospital, Harvard Medical School.
"I've suffered emotionally and physically from eczema since I was a
baby," says Sarah Robb, fourteen year-old eczema sufferer. "I couldn't
sleep, I couldn't wear tank tops to school without embarrassment and I
even had to give up going to summer camp with the other kids. Protopic
ointment has cleared my skin. I'm wearing tank tops to school and
taking part in all the activities, even camp, that I couldn't before.
I feel like I can live normally again -- and so can my family."
Currently, however, those with vitiligo
should be aware that the Protopic label does
not mention "vitiligo" specifically, and the
Food and Drug Administration regulatory
requirements do not support the clinical
investigation or use of Protopic at this
time. We are hopeful that study results will
eventually lead to such an approval
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