Safety Study of Elidel (Pimecrolimus) 1% Cream to Treat Netherton Syndrome

Inclusion Criteria: * Clinical diagnosis of Netherton syndrome * Normal laboratory values within 3 months prior to enrollment * Signed written informed consent * Willingness and ability to comply with the study requirements * For women of childbearing age, negative urine pregnancy test at enrollment and then monthly thereafter; women of childbearing age who are not abstinent must use contraception. Exclusion Criteria: * Clinically significant physical examination or laboratory abnormalities * Clinical evidence of liver disease or liver injury as documented by abnormal liver function tests * Symptoms of a significant acute illness in the 30 week period preceding the start of treatment * Patients with known serious adverse reactions or hypersensitivity to macrolides or calcineurin inhibitors or with known hypersensitivity to any of the ingredients of the study medication or history of adverse reactions to the anesthetic product used for blood draws * Topical tacrolimus or Elidel within 2 weeks prior to dosing * Systemic steroid, systemic tacrolimus, or any immunosuppressant within 1 month prior to dosing * Phototherapy within 1 month prior to dosing * Use of inhibitors of Cytochrome P450 3A4 (CYP3A4) iso-enzyme within 2 weeks prior to dosing * Topical steroids or other topical therapy (except tacrolimus) may be used up to the day of 1st application of Elidel; however, treatment must be discontinued during the treatment period. Topical treatment of corticosteroids may resume …