Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Monad 1 · 1 trial · 1 indication
Change in hemorrhoidal symptoms (pain, burning, itching, and swelling) as measured by the patient using a numeric rating scale.
| Arm | Type | Description |
|---|---|---|
| Monad 1 cream | ACTIVE_COMPARATOR | Topical cream applied to the peri-anal area twice daily for seven days. |
| Monad 2 cream | ACTIVE_COMPARATOR | Topical cream applied to the peri-anal area twice daily for seven days. |
| Monad 3 cream | ACTIVE_COMPARATOR | Topical cream applied to the peri-anal area twice daily for seven days. |
| Combination-CITI-002 (low dose) cream | EXPERIMENTAL | Topical cream applied to the peri-anal area twice daily for seven days. |
| Combination-CITI-002 (high dose) cream | EXPERIMENTAL | Topical cream applied to the peri-anal area twice daily for seven days. |
| Name | Type | Description |
|---|---|---|
| Monad 1 | DRUG | Single therapy cream containing Lidocaine. Lidocaine is a topical anesthetic. |
| Monad 2 | DRUG | Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid. |
| Monad 3 | DRUG | Single therapy cream containing Halobetasol Propionate (high strength). |
| Combination - CITI-002 (low dose) | DRUG | Combination cream containing Lidocaine and HBP (low) |
| Combination - CITI-002 (high dose) | DRUG | Combination cream containing Lidocaine and HBP (high) |
Inclusion Criteria: * Male or non-pregnant female 18 years of age or older. * Signs written informed consent for the study. * Females must be post-menopausal , surgically sterile , or use an effective method of birth control, or women of childbearing potential (WOCBP) must have a negative Urine Pre...