 - Has received any of the following medications or therapies within 4 weeks prior to randomization: systemic non-steroid immunosuppressive or immunomodulatory drugs; systemic corticosteroids; high daily dose of inhaled corticosteroids; topical corticosteroids of strongest potency for atopic dermatitis; topical antihistamines including topical doxepin; topical anesthetics; topical nonsteroidal anti-inflammatory drugs; topical counter-irritants eg, capsaicin, menthol, wintergreen oil; antidepressants or antipsychotics; soporifics; phototherapy including ultraviolet A , ultraviolet B, and psoralen with ultraviolet A PUVA; hyposensitization desensitization therapy 