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A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase II Study to Evaluate the Efficacy, Tolerability, and Safety of Topical VBP-245 in Pediatric Subjects for the Treatment of Molluscum Contagiosum (VBP-245-MCV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VBP-245 | Experimental | VBP-245 Topical Gel Applied to Affected Area BID |
|
| Vehicle | Placebo Comparator | Vehicle Gel Applied to Affected Area BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBP-245 Topical Gel | Drug | Topical application BID |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in number of MCV lesions | Number of lesions from baseline to day 60 will be counted and the reduction in number will be recorded. | 60 days |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria:
Exclusion Criteria:
Subjects meeting the following exclusion criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Jayashri Krishnan, PhD | JSS Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia Institute of Dermatology | Fort Washington | Pennsylvania | 19034 | United States | ||
| Parkside Pediatrics |
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| ID | Term |
|---|---|
| D008976 | Molluscum Contagiosum |
| D017193 | Skin Diseases, Viral |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Drug |
Vehicle Control With No Active Pharmaceutical Ingredients |
|
| Greenville |
| South Carolina |
| 29607 |
| United States |
| Coastal Pediatrics | Mt. Pleasant | South Carolina | 29464 | United States |
| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |