Recent Developments

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).