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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03981822 | A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts | PHASE2 | COMPLETED | 105 | — | — | Jun 25, 2019 | Jul 8, 2020 | Nov 27, 2024 | 4 | United States |
Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.
| Arm | Type | Description |
|---|---|---|
| Part A: VP-102 2 hour-Active | ACTIVE_COMPARATOR | For part A, VP-102 will be applied for 2 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 2 hours and removed.In both parts, VP-102 is applied every 21 days for 4 treatments. |
| Part A: VP-102 6-hour Active | ACTIVE_COMPARATOR | For part A, VP-102 will be applied for 6 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 6 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments. |
| Part A: VP-102 24-hour Active | ACTIVE_COMPARATOR | For part A, VP-102 will be applied for 24 hours and removed. If selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments. |
| Part A: Placebo | PLACEBO_COMPARATOR | For part A, VP-102 will be applied for 2-,6- or 24- hours and removed. Placebo is applied every 21 days for 4 treatments. |
| Part B & A: VP-102 6 hour-Active | ACTIVE_COMPARATOR | Part B, VP-102 will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| Part B & A: 6-hour-Placebo | PLACEBO_COMPARATOR | Part B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| Part B & A: VP-102 24-hour Active | ACTIVE_COMPARATOR | For part A, VP-102 will be applied for 24 hours and removed. If 24 hours is selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| Part B & A: 24-hour-Placebo | PLACEBO_COMPARATOR | Part B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| Name | Type | Description |
|---|---|---|
| VP-102 and applicator | COMBINATION_PRODUCT | In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. |
| Placebo | COMBINATION_PRODUCT | The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin |
Key Inclusion Criteria: * Be healthy, immunocompetent males or females ≥ 18 years of age * Present with ≥ 2 and ≤ 30 external genital and/or perianal warts in ≥ 1 of the following anatomic areas: * In both sexes: medial thigh (except inguinal fold); supra-pubic, perineal, and perianal areas * ...