Atopic dermatitis treatment hindered by FDA ruling, patient non-compliance

National report - Several new treatments are now available for atopic, contact and seborrheic dermatitis, while the use of two older drugs has declined sharply since the Food and Drug Administration (FDA) mandated the inclusion of "black box" label warnings.

Among the relatively new treatments: Vanos (Medicis) was approved last year for treatment of inflammatory and pruritic conditions including dermatitis, and Stiefel/Connetics offers two new formulations of medication in a foam base: Olux-E and Verdeso.

Newer treatments kinder to cracked, dry skin

"Olux-E is an emollient version of Olux and is designed for areas that need moisturizing as well as treatment," says Joel Schlessinger, M.D., president of the American Society of Cosmetic Dermatology & Aesthetic Surgery and director of Skin Specialists P.C., Omaha, Neb.

He says Verdeso foam is a form of desonide in an emollient formulation.

"It can be used anywhere on the body," Dr. Schlessinger says. He adds that in the study the "medication performed exceptionally well in kids and even in children with cracked, dry skin. We started our trial on Verdeso foam in the dead of winter in Omaha, and I had my doubts that the product would do well due to the terrible nature of eczema in wintertime and my previous concerns about foams on dry, cracked skin.

"The fact of the matter is that none of the children in this study dropped out due to irritation - that was a pretty amazing thing to see. The vehicle of this product is very nice and offers a great treatment option for adults, as well. It will be especially useful for areas of the face and neck affected by seborrheic dermatitis."

Dr. Schlessinger also says that Clobex (Galderma) lotion and spray have impacted the types of patient issues he can address, especially when it comes to large body areas. He adds that narrowband UVB and UVB therapies are still being used for eczema in severely affected individuals, but that they aren't considered standard treatment in most mild-to-moderate cases.

Medication concerns

"All of the treatments I mentioned, except Verdeso foam, are super-potent steroids, so there will always be some concern about side effects such as striae if used for periods greater than two weeks or in potentially occluded areas," he says.

"But what our studies showed is that they are safe and effective in both the pediatric and adult population."

Not so safe, at least according to the FDA, are Elidel (Novartis) and Protopic (Astellas), two drugs used in the treatment of atopic dermatitis. Last year, the FDA ruled that they must carry "black box" label warnings linking their use to a possible risk of cancer. Dr. Schlessinger says the FDA's ruling - which many dermatologists view with skepticism - has caused a considerable shift in his treatment paradigm.