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Paronychia is inflammation of the skin surrounding the nail that leads to secondary infection. Iatrogenic paronychia has been clearly associated with cancer chemotherapies. This phase-2 trial is a dose finding study and will evaluate topical VBP-926 solution against a vehicle control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower concentration VBP-926 | Active Comparator | VBP-926 solution applied to affected area BID |
|
| Higher concentration VBP-926 | Active Comparator | VBP-926 solution applied to affected area BID |
|
| Vehicle | Placebo Comparator | Vehicle solution applied to affected area BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBP-926 | Drug | Topical VBP-926 solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Downgrading of the 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) in adult cancer patients with chemotherapy-associated paronychia | Treatment responses will be assessed by clinical grading utilizing a morphologic 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) and will be assessed from baseline to 8 weeks for each affected nail. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayashri Krishnan, PhD | JSS Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Compassionate Cancer Care | Fountain Valley | California | 92708 | United States | ||
| Northwestern University Department of Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31240513 | Derived | Capriotti KD, Anadkat M, Choi J, Kaffenberger B, McLellan B, Barone S, Kukoyi O, Goldfarb S, Lacouture M. A randomized phase 2 trial of the efficacy and safety of a novel topical povidone-iodine formulation for Cancer therapy-associated Paronychia. Invest New Drugs. 2019 Dec;37(6):1247-1256. doi: 10.1007/s10637-019-00825-0. Epub 2019 Jun 26. |
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Once subjects have been determined to be eligible for participation in the study, they will be randomized to one of the three treatment arms. The randomization number will be generated according to the randomization schedule prepared prior to the start of the study. Participants will be assigned to receive assign treatment solution VBP-926 (either lower or higher concentration) or vehicle in 1:1:1 ratio using the IWRS system.
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The randomization will be done centrally by a randomization programmer/statistician who will be the only un-blinded participant. That person will not have any part in the decisions regarding patient populations and/or protocol violations.
| Chicago |
| Illinois |
| 60611 |
| United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10022 | United States |
| Montefiore Einstein Center for Cancer Care | The Bronx | New York | 10461 | United States |
| Oncology Specialists of Charlotte | Charlotte | North Carolina | 28207 | United States |
| Ohio State University | Columbus | Ohio | 43221 | United States |
| Bryn Mawr Skin & Cancer Institute | Bryn Mawr | Pennsylvania | 19010 | United States |