The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)

"In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.~For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.~Dilutions of omalizumab and its excipients were in SWFI."

"In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation.~For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.~Dilutions of omalizumab and its excipients were made in saline."