^PrSeaford Nifedipine and Lidocaine HCl Cream is indicated in adults for the management of chronic primary anal fissure unresponsive to stool softeners and topical anesthetic agents.

* Difference in healing rates vs. lidocaine + hydrocortisone (94.5% vs. 16.4%) was 78.1%; p<0.001.

Study P001/98 was a randomized double-blind parallel controlled study conducted in 110 patients aged 18 years and older with chronic anal fissure. Patients were mainly males (72%) with no underlying pathology or concomitant local condition, such as neoplasms, fistulas, perianal abscess, or prolapse. Patients had a history of anal pain for at least two months despite treatment with stool softeners and topical anesthetic agents. Patients were randomized into two treatment groups to receive either Seaford Nifedipine and Lidocaine HCl Cream or a control ointment (hydrocortisone acetate 1% with lidocaine 1.5%). The participants administered 3 g of ointment twice daily for 
3 weeks and lay on the left side on the bed for three to five minutes. The primary efficacy endpoint on day 21 of treatment was healing of the fissure with epithelialization 
or scarring.