Atopic dermatitis almost always begins in childhood, usually during infancy. Physicians estimate that 65 percent of eczema patients are diagnosed in the first year of life and 90 percent of patients experience it before age five.

"These results indicate that Elidel may offer significant therapeutic advantages over other treatment strategies in the long-term management of chronic eczema in infants and young children," said Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology, Children's Hospital, San Diego and Clinical Professor of Pediatrics and Medicine (Dermatology), University of California, San Diego. "A steroid-free therapy like Elidel provides a new alternative for this difficult-to-treat young patient group."

Study Details
The 12-month, multi-center, double-blind controlled trial studied 251 infants (3-23 months old). The study compared the safety and efficacy of a long-term Elidel treatment regimen with a current widely accepted conventional therapy regimen of emollients and, when necessary, moderately potent corticosteroids, assessing the long-term safety and efficacy of Elidel. In both treatment groups, emollients were used to treat underlying dry skin. Caregivers applied either Elidel or placebo cream at the earliest signs or symptoms of the disease. Topical corticosteroids of mid-potency were used by both treatment groups to treat any severe flares.

Results of this study showed that Elidel significantly reduced the incidence of flares over both six and 12 months. The proportion of patients who completed with no flares was approximately twice as high in the Elidel group compared with the control group (67.6% versus 30.4%, during the first 6 months; 56.9% versus 28.3%, over the full 12 months).

The study also demonstrated Elidel to have a steroid-sparing effect. Overall, corticosteroid use was substantially lower in the Elidel group: 63.7% of the Elidel group used no corticosteroids during the 12-month study compared with 34.8% of patients in the control group. Elidel was found to be safe and well tolerated; there were no clinically significant difference in the incidence of adverse events between Elidel and the control group.

About Elidel
Elidel is the first steroid-free prescription cream for mild to moderate eczema patients as young as two years old. It is approved for the short-term and intermittent long-term treatment of mild to moderate eczema in non-immunocompromised patients, for whom conventional therapies are inadvisable because of potential risks, inadequate response, or intolerance. Currently, eczema affects up to 17% of the U.S. population. Mild to moderate sufferers make up the vast majority of this eczema patient population. As conventional therapies can be inadvisable and/or ineffective for many of these eczema patients, Elidel serves as a valuable treatment option for this large population.

Elidel, which was approved by the FDA in December 2001, is available in tubes of 15 g, 30 g and 100 g. The approval was based on safety and efficacy results of clinical trials in more than 1700 pediatric and adult patients. The most common side effect on the skin was a mild to moderate, temporary feeling of warmth or burning (occurring in 8% of children aged 2-17 years and in 26% of adults). This side effect was temporary and its occurrences were comparable to those experienced by patients on placebo cream. Other common side effects included headache and cold symptoms. Elidel did not induce contact sensitization, phototoxicity or photoallergy, nor did it show any cumulative irritation. Elidel did not elicit skin atrophy, sometimes seen with long-term topical corticosteroid use.

Developed by the Novartis Research Institute, Elidel may be used on all skin surfaces, including delicate areas such as the face, neck and skin folds. The active ingredient is pimecrolimus, which is derived from ascomycin, a natural substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus. Pimecrolimus selectively blocks the production and release of cytokines from T-cells. These cytokines in the skin cause the inflammation, redness and itching associated with eczema.