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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03186378 | Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum. | PHASE2 | COMPLETED | 33 | — | — | Jun 8, 2017 | Jun 25, 2018 | Aug 11, 2021 | 1 | United States |
The primary objective is to determine any potential systemic exposure from a single 24-hour dermal application of VP-102 topical film-forming solution when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older.
| Arm | Type | Description |
|---|---|---|
| Exposure Group | EXPERIMENTAL | This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator. |
| Standard Group | EXPERIMENTAL | This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator. |
| Name | Type | Description |
|---|---|---|
| VP-102 with applicator | COMBINATION_PRODUCT | Subjects will receive treatment to their molluscum contagiosum with VP-102. |
Inclusion Criteria: 1. Be healthy subjects ages 2 years and older. 2. Patients with 1-20 lesions may be enrolled and treated in the standard treatment group but are not eligible for the exposure study. 3. Patients with 21 or more lesions may only be enrolled in the exposure group. Subjects particip...