National report - New topical steroids that have recently hit the market may not be for everyone, but for the right pediatric patients, the products represent exciting new developments in the treatment of pediatric dermatoses, says Joel Schlessinger, M.D., director of the Advanced Skin Research Center in Omaha, Neb., and president of the American Society of Cosmetic Dermatology and Aesthetic Surgery.
One of the most intriguing new topicals is the corticosteroid Vanos (0.1 percent fluocinonide, Medicis), granted expanded approval by the Food and Drug Administration (FDA) in 2006 for use as primary therapy for inflammatory and pruritic manifestations of all corticosteroid-responsive dermatoses in patients ages 12 years and older. Fluocinonide 0.1 percent cream previously had FDA approval for twice-daily use in the treatment of adults with plaque-type psoriasis affecting up to 10 percent of body surface area.
Vanos cream is notable for a number of reasons - significantly, the steroid breaks the paradigm of the twice-daily topical steroid by offering efficacy with once-a-day use. Clinical studies on the cream showed that once-daily and twice-daily use were similarly effective (59 percent versus 57 percent) for achieving clearance or near clearance of symptoms over a period of two weeks. Adverse events in the clinical trials included headache and a burning sensation at application site.
"I was thrilled to see that this formulation, when used in once-daily topical application, didn't cause any hypothalamic-pituitary-adrenal axis disruption in the youngest group of patients (ages 3 months to 6 years)," Dr. Schlessinger tells Dermatology Times.
"It has always been assumed that higher-strength topical steroids were not able to be used in the pediatric population without significant risks, but this study didn't seem to show that," he adds.
Due to a lack of long-term data, treatment with Vanos should be limited to two consecutive weeks at a maximum dose of 60 g per week. And Dr. Schlessinger says steroid atrophy and striae are still concerns with pediatric patients, but he suggests that in patients with particularly tough dermatoses, the cream represents an effective option.
When he does prescribe Vanos, Dr. Schlessinger says he takes some extra precautions, due to the higher strength.
"When I prescribe these in my pediatric patients, I strongly explain to the parents the importance of not overusing these drugs," he says. "I bolster this by not giving refills if I suspect they won't need them for more than two weeks, to make sure they don't overuse them.
"Additionally, I try to make sure they know how important it is to avoid the face, neck and groin area," he says. "There are certain patients who simply won't be a candidate for these due to poor parental skills, but that shouldn't keep the ones who are good candidates from obtaining these drugs."
Newer foam formulations are also adding to the options for treating more difficult dermatoses cases.
Verdeso (desonide 0.05 percent foam; formerly Desilux, Connetics), a low-potency topical steroid recently approved for ages 3 months and older, and Olux-E (clobetasol propionate 0.05 percent foam, Stiefel), approved for patients ages 12 and over, were both shown to be effective in addressing severe atopic dermatitis in pediatric patients in studies in which Dr. Schlessinger participated.
"We were especially impressed that the foam emollient formulation was well-tolerated during the winter, when the study was conducted," he says. "My office is in Omaha, Neb., and wintertime in Omaha is a brutal experience, so I give Stiefel credit for conducting this study during the winter.
"The amazing thing is that the kids in this study had minimal complaints about the foam, something that we were worried about when going into the study," he adds.