Time-tested ingredients, fresh entities provide contemporary therapeutic options

January 1, 2008

Several new medications have become available for the treatment of dermatologic disorders in the past year. They include formulations of time-tested ingredients in enhanced vehicles as well as newer entities with safety and/or efficacy advantages.

Key Points

Las Vegas - A mix, comprising both brand-new entities and several reformulations of "oldies but goodies," describes what is new in the medicine chest for dermatologists, says James Q. Del Rosso, D.O., clinical assistant professor of dermatology at both the University of Nevada School of Medicine and Touro University College of Osteopathic Medicine, and dermatology residency director, Valley Hospital Medical Center, Las Vegas.

Speaking at the Fall Clinical Dermatology Conference, Dr. Del Rosso discussed recent advances in topical and oral pharmacotherapy for dermatologic disorders, including seborrheic dermatitis, corticosteroid-responsive dermatoses, wound healing and photoaging.

Seborrheic dermatitis

The first, a gel (Xolegel, Barrier Therapeutics), is indicated for treatment of seborrheic dermatitis in immunocompetent adults and children ages 12 and older.

Its efficacy and safety were established in three clinical trials including more than 900 patients.

After 28 days of treatment in the pivotal trial, about 25 percent of patients using the ketoconazole gel achieved success, defined as absent or very mild disease with an improvement by at least two grades.

Results of an active comparator-controlled efficacy study showed there was no advantage to adding desonide to the ketoconazole 2 percent gel, as the new antifungal formulation outperformed both the combination as well as the corticosteroid alone.

The second new ketoconazole product is a hydroethanolic foam (Extina, Stiefel) indicated for treating seborrheic dermatitis on the scalp, face and chest.

In a study in which the foam was applied twice daily for four weeks, it outperformed both the vehicle control and ketoconazole cream 2 percent, based on an assessment of proportions of patients achieving clear or almost clear ratings.

"The characteristics of the foam formulation allow for application on both scalp and glabrous skin sites. Although off-label, use of ketoconazole 2 percent foam for truncal tinea versicolor is a rational option due to the ease of spreading the foam vehicle diffusely on the trunk and proximal extremities," Dr. Del Rosso tells Dermatology Times.

Corticosteroid responsive dermatoses

Two new formulations of desonide 0.05 percent have been recently introduced.

One new formulation is an alcohol-free, petrolatum-based emollient foam (Verdeso, Stiefel) approved for the treatment of mild to moderate atopic dermatitis in children as young as 3 months of age.

"Foams are pharmaceutically elegant vehicles because they are easy to spread and leave no residue. However, based on patient evaluations, the new petrolatum-based foam vehicle (VersaFoam-EF) has an added benefit of providing a moisturizing effect. Without any alcohol, it is also very well-tolerated, even when used on eczematous skin," Dr. Del Rosso says.

In clinical testing, the emollient foam was established to provide superior cutaneous penetration of the active ingredient relative to branded desonide cream and ointment preparations. In pivotal trials evaluating its efficacy for atopic dermatitis, 58 percent of patients treated with the desonide foam achieved success after four weeks, compared to 21 percent of vehicle-treated controls.

Most patients enrolled had moderate disease, and success was rigorously defined as an overall rating of clear or almost clear with a minimum two-grade improvement and absence of or minimal erythema and induration.

"Atopic dermatitis patients generally experience stinging and burning when applying a hydroethanolic foam, but in the pivotal trial, less than 3 percent of patients using the petrolatum-based desonide foam experienced any application site reactions."

Desonide 0.05 percent has also been formulated in a new hydrogel vehicle (Desonate, Skin Medica) that was proven to enhance skin hydration based on corneometry measurements and to reduce transepidermal water loss.

"Thus, the hydrogel vehicle allows for enhanced moisturization, an important factor when treating atopic dermatitis," Dr. Del Rosso says.

In the pivotal trials where atopic dermatitis patients were treated for four weeks, 58 percent of patients using the desonide hydrogel achieved treatment success, with particularly rapid improvement in pruritus and burning.

In this trial, the proportion of patients with moderate to severe pruritus decreased from 80 percent at baseline to 20 percent within two weeks.