4-Day Primary Irritation Patch Test of MIS Solution

Inclusion criteria

• . Were male or female, 18 - 75 years of age, in general good health (confirmed by medical history);
• . If females of childbearing potential, were using an acceptable form of birth control (i.e., oral contraceptive, intra-uterine device \[IUD\], diaphragm, condom, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who had a vasectomy);
• . In the case of females of childbearing potential, had a negative urine pregnancy test (UPT) at Screening (a woman was considered to be of non-childbearing potential if she was postmenopausal for at least 12 months or was surgically sterile \[hysterectomy, bilateral oophorectomy\]);
• . Agreed not to use systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
• . Agreed not to use systemic/topical analgesics such as aspirin (81 mg daily aspirin were allowed at the discretion of the Investigator), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen was permitted);
• . Were free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, interfered with the study results or increased the risk of adverse events (AEs);
• . Were of any skin type or race providing the skin pigmentation allowed for discernment of erythema;
• . Completed a medical screening procedure; and