Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02482428 | Efficacy and Tolerability of Topical LFX453 for External Genital Warts | PHASE2 | COMPLETED | 88 | — | — | May 12, 2015 | May 31, 2016 | Jan 5, 2021 | 1 | United States |
Number of participants achieving complete clearance of genital warts at Week 14
Number of participants with at least one AE/SAE in the category up to 30 weeks
| Arm | Type | Description |
|---|---|---|
| LFX453 0.1% NMC | EXPERIMENTAL | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
| LLFX453 0.15% LCC | EXPERIMENTAL | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
| Vehicle to NMC | PLACEBO_COMPARATOR | Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
| Vehicle to LCC | PLACEBO_COMPARATOR | Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
| Aldara | ACTIVE_COMPARATOR | Aldara 5% cream 3 applications per week for a maximum of 16 weeks |
| Name | Type | Description |
|---|---|---|
| Investigational Treatment | DRUG | Applied twice daily for up to 12 weeks |
| Aldara | DRUG | Applied 3 times a week for 16 weeks |
Inclusion Criteria: * Signed informed consent * Circumcised male 18-60 years * Clinical diagnosis of external genital warts * Agree to remain abstinent or to use condoms during intercourse for the duration of the study * Agree to digital photographs of treated area Exclusion Criteria: * Any treat...