New Data for Briakinumab Presented in Europe
Results from new studies presented at the European
Association of Dermatology and Venereology show
that briakinumab (Abbott) may be superior to
methotrexate, etanercept, and placebo in the treatment
of moderate to severe psoriasis. In the one-year
M10-255 study, 81.8 percent of patients receiving briakinumab
achieved PASI 75 at week 24, compared
with 39.9 percent of those treated with methotrexate.
At 52 weeks, 66.2 percent of patients maintained 75
percent clearance, compared with 23.9 percent of
patients treated with methotrexate. Complete clearance
was seen in 45.5 percent of briakinumab-treated
patients, compared with 9.2 percent of methotrexate
patients. Two other trials reported at the conference
showed that briakinumab was markedly superior to
both etanercept and placebo. However, three cases of
cancer were reported in the briakinumab group in the
52-week study, and four patients experienced serious
infections. Abbott has filed applications for US and
European approval of the drug.
FDA Updates Safety Requirements
FDA issued a final rule that clarifies what safety
information must be reported during clinical trials of
investigational drugs and biologics. The new rule
requires that certain safety information that previously
had not been required to be reported to the
FDA be reported within 15 days of a sponsor becoming
aware of an occurrence. These reports include
findings from clinical or epidemiological studies that
suggest a significant risk to study participants, as
well as serious suspected adverse reactions that
occur at a rate higher than expected. In addition,
serious adverse events from bioavailability and bioequivalence
studies must be reported.
Short-contact BPO Foam Reduces P. Acnes
A new study presented at the Fall Clinical
Dermatology Conference in Las Vegas shows that
benzoyl peroxide 9.8% foam when used in short contact
reduces P. acnes populations on the back. In a
two-week, open-label study, 20 patients were treated
once daily for two weeks with BPO (9.8%) foam,
applied to skin and left in place for a period of time
then washed off. Mean reduction of P. acnes counts
on the back was 0.91 log per cm2 after one week of
treatment, and 1.66 log per cm2 after two weeks,
equivalent to a 98.3 percent reduction. Researchers
noted that short-contact BPO (9.8%) foam is especially
effective with two minutes of skin contact time and
that application to non-moistened skin may allow for
longer BPO skin contact time between application
and rinsing than is achieved with a BPO cleanser.
Looking and Giving Better
Clarisonic recently partnered with “Look Good…Feel
Better,” a national public service that helps women
with breast cancer and other cancers manage their
treatment and recovery. “Look Good…Feel Better”
teaches techniques such as how to deal with skin
dryness, nail care, and makeup application. Clarisonic
will donate $5 to “Look Good…Feel Better” from
every PINK Skin Cleansing System (retails for $195)
purchased and $4 from every Clarisonic PINK Mia
Skin Cleansing System ($149) purchased.
Beginning in October, $15 from each
purchase of the new limited edition
Clarisonic Hope
Mia ($149) was
donated.
Skincare Innovators Recognized.
Drs. Eugene Van Scott and
Ruey Yu have been awarded the Cosmetic Surgery Forum (CSF)
Innovators in Cosmetic Dermatology Award. The founders of
NeoStrata Company, Inc. are internationally recognized for the
groundbreaking discovery that Alpha Hydroxy Acids (AHAs) have
profound beneficial effects on human skin. “Their passion and
vision led to their subsequent research, which established AHAs are
not only beneficial in the treatment of dermatological conditions,
but are also effective in stimulating prematurely aged or damaged
skin to actually rejuvenate itself, thereby revolutionizing the treatment
of aging skin,” Dr. Schlessinger, Chair of CSF, observed.
“This was the start to the true over-the-counter cosmeceutical
revolution. When these treatments were popularized it awakened
the realization in consumers that products could actually benefit
the skin, rather than simply sit on it, hiding imperfections,” Dr.
Schlessinger added.
The award will be formally distributed at the CSF in Las Vegas December 2-4 (cosmeticsurgeryforum.com).
