Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures

Inclusion Criteria: 1. Males or females, aged ≥ 18 to ≤ 75 years. 2. Subjects with evidence of a circumscribed fissure, with induration at the edges. 3. Subjects with AF-related pain associated with or following defecation occurring at least 2 times a week for at least 28 days prior to signing the informed consent form (ICF). 4. AF-related pain associated with or following defecation of at least 5 on an 11-point numerical rating score scale (NRS) at the last defecation prior to signing the ICF (0 being no pain; 10 being the worst possible pain). 5. Average AF-related pain associated with or following defecation of at least 5 on an 11-point NRS during the last 3 days in which subject had a defecation during the 7 days prior to randomization. 6. Any female of non-childbearing potential, including any female who: a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post menopausal (demonstration of total cessation of menses for ≥ 1 year from the date of screening visit). 7. Females of child bearing potential who agree to use at least one form of contraception (may be a barrier method), during the full duration of the study. 8. Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 9. Capable of using the IVRS and able to adequately communicate comprehension of the IVRS questions to the investigator. 10. Capable of and freely willing to provide written informed consent prior to participating in the study. Exclusion Criteria: 1. Unwilling to have visual or medical examination of the AF. 2. More than 1 AF. 3. Subjects with AF associated with or caused by other conditions, including but not limited to: drug-induced, trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis or malignancy. 4. Unwilling to stop all other concomitant topical preparations applied in and around the anus from signing of ICF through Day 29 of the study. 5. Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 28 days prior to signing the ICF. 6. Unwilling to discontinue use of sitz baths for up to 4 hours after each application of investigational product from signing of ICF to end of study. 7. Unwilling to discontinue use of anesthetics from signing the ICF to end of study. 8. Subfissure injection of botulinum toxin in the 3 months prior to signing the ICF. 9. Known sensitivity to investigational product(s) or calcium channel…