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New Study at Wake Forest Shows Tacrolimus Ointment May be an Effective And Safe Alternative for Children Under Age Two With Eczema: Presented at AAD

WINSTON SALEM, NC -- August 2, 2002 -- Data presented at the ACADEMY 2002 Summer Meeting of the American Academy of Dermatology in New York City suggests that tacrolimus ointment may be an effective and safe alternative for children under age two with atopic dermatitis.

The six-month multi-center study evaluated the utilization patterns for the age, sex and response to therapy of tacrolimus ointment. The study included 37 patients under the age of two with moderate to severe atopic dermatitis. Fifteen patients had follow-up visits, all of who reported improvement at one or more of 23 subsequent visits. Both concentrations of tacrolimus ointment (0.03% and 0.1%) were effective, and adverse events were uncommon. No patients discontinued treatment due to adverse events, specifically, burning, pain, stinging and itching at the application site.

"This study shows that the use of tacrolimus ointment may become the standard of care in children less than two years old," said Alan Fleischer, M.D., Professor of Dermatology at Wake Forest University School of Medicine, the coordinating center for the study.

Tacrolimus ointment is the first in a new class of prescription drugs called topical immunomodulators, or TIMs, to be developed in more than 40 years for the treatment of eczema. The FDA approved the steroid-free alternative in December 2000 for moderate to severe eczema in children and adults.

Low potency topical corticosteroids are the current standard of therapy for eczema in young children. Most topical and systemic corticosteroids have not been approved by the FDA for use in children less than two years of age. Conservative treatment such as the use of lotions often fails in this age group.

"This study further suggests the role tacrolimus may play for long term use in children under two years of age," said Fleischer. "Infants suffer the most from eczema and dermatologists, up to now, have been without safe, steroid-free options, therefore this data brings us great optimism in terms of treating eczema."

In clinical studies, when compared to mid and high potency topical corticosteroids, tacrolimus was found to be safe for use on the sensitive areas of the face, neck and hands. In addition, tacrolimus was not found to be absorbed into the bloodstream.

Tacrolimus is available in two concentrations for adults, 0.03 percent and 0.1 percent. For children two to 15 years of age, only the 0.03 percent concentration is indicated. Similar to other dermatological products currently on the market, patients should practice safe sun techniques to avoid direct exposure to natural or artificial sunlight when using tacrolimus.

As Wake Forest University Baptist Medical Center, Wake Forest University School of Medicine and The North Carolina Baptist Hospitals, Incorporated comprise one of the major academic medical centers in the United States. The Medical Center, within the limits of its resources, commits itself to serve society by providing superior education for students and teachers of medicine and related health professions; by rendering a continuum of exemplary and efficient patient care in an environment which emphasizes scholarship and human dignity and principles embodied in the Judeo-Christian traditions; by fostering the discovery and application of new knowledge through basic and clinical research in the biomedical and relevant social sciences; and by cooperating with the community, region and nation through active participation in efforts to improve the health and well-being of the community.


SOURCE: Wake Forest University Medical Center

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