Women of childbearing potential who are not using adequate contraception.

Women who are pregnant or breastfeeding.

Subjects on unstable regimens of Crohn's therapy (e.g. tumor necrosis factor (TNF) inhibitors, immunosuppressants, steroids).

Subjects taking strong analgesics that could interfere with pain measurements. Subjects with a perianal abscess requiring incision and drainage.

Subjects with anal stenosis.

Subjects with fistulae outside the immediate perianal area.

Subjects who have had abdominal surgery for Crohn's disease within the past 12 weeks.

Subjects who have had significant anorectal surgery for Crohns disease within the past 8 weeks.

A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease