New actinic keratoses therapies take shape: Cosmetic component will always cloud reimbursement

May 1, 2008

In the treatment of actinic keratoses, Peplin, a topical gel made from the sap of the Australian Euphorbia peplus, and cosmetic therapies show promise for preventing recurrences, but likely won't ever be front-line treatments. Meanwhile, the one treatment approved by the U.S. Food and Drug Administration treatment that also offers cosmetic benefits, ALA-PDT, comes with coding issues that some say make it difficult for doctors to obtain reasonable compensation.

Key Points

Houston - In approaching actinic keratosis (AK), fluorouracil (Fluoroplex [Allergan], Carac [Dermik] and Efudex [Valeant]) remains the gold standard treatment of choice, with treatments including imiquimod falling close behind, but new therapies coming down the pike soon could include an innovative new topical gel based on a traditional skin remedy, and a gentler form of imiquimod that has fewer side effects.

The topical gel product, which is moving on to phase 3 clinical trials for AKs is from Australia-based Peplin. The product contains PEP005, a class of compounds derived from the sap of the Australian Euphorbia peplus, (E. peplus), also known as milkweed, and long used as a traditional treatment for everything from warts and corns to skin cancers and precancerous skin lesions.

Peplin reports that it has completed a phase 2b clinical trial involving 220 patients.

Preliminary results showed that the product had a favorable safety profile, and it was well-tolerated. In the highest-dose group using the product, 75 percent of patients had clearance of three-quarters or more of their lesions, while 56 percent had lesion clearance of three-quarters or more.

If approved, the new formulation would involve a short treatment regiment of two to three days of application that patients could perform at home.

"(Peplin) does appear to be quite exciting, because the rate of removal of AKs (and basal cell carcinomas, for that matter) seems to be relatively high compared to the effort expended, which can be just one or two treatments," says Ted Rosen, M.D., chief of the VA Dermatology Clinic and professor in the department of dermatology at Baylor College of Medicine here.

"The results of the phase 2 study are very positive," he says.

In other developments, hopes are high that new formulations of topical imiquimod 5 percent cream (Aldara, Graceway Pharmaceuticals) will produce a product that offers the same excellent outcome, but is less irritating to the skin. Graceway reports that phase 3 trials are under way on the product to reduce imiquimod's notorious side effects.

Meanwhile, AK resolution and prevention is popping up more frequently in cosmetic dermatology literature, with physicians finding that, in addition to improving wrinkles and photodamage, some laser therapies appear to be taking aim at AKs.