Chemotherapy-Associated Paronychia Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Vehicle-controlled, Phase-2 Trial to Evaluate the Efficacy and Safety of Two Concentrations of VBP-926 Solution for the Treatment of Chemotherapy-associated Paronychia in Cancer Patients
| Verified date | January 2019 |
| Source | Veloce BioPharma LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 102 |
| Est. completion date | September 18, 2018 |
| Est. primary completion date | July 17, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Males or females aged 18 years or older - Acute paronychia developing during the course of their monotherapy or combination chemotherapy - Involvement of at least one nail with a Paronychia Severity Grading score of 1 or higher - Eastern Cooperative Oncology Group score = 2 - Life expectancy of at least 12 months as per the investigator's judgment - Willing to provide written informed consent - Individuals who are willing to not start any new products OTC or prescription treatments for Paronychia and discontinue any treatment the investigator feels may interfere with the evaluation of the test products - Individuals who are already on antibiotics as prescribed by oncologist for any condition except paronychia - Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s) Exclusion Criteria: - Mentally incompetent or unable or not willing to give written informed consent or meet study requirements - Without a history of a cancer diagnosis - Without history of cancer diagnosis using chemotherapy - Patients with paronychia requiring surgical intervention at baseline - Patients who are already on prescribed treatment for paronychia who are not willing to discontinue this treatment and only use study drug (no washout period required) - Neutropenia (absolute neutrophil count < 1500 cells/µL) - Patient Human Immunodeficiency Virus (HIV) infection - Patients with any medical condition, including alcohol or drug abuse or mental incapacity / hypersensitive to the study drug, which in judgment of the investigator will interfere with the patient's participation in the study or evaluation of study results - Have any medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk |
| Country | Name | City | State |
|---|---|---|---|
| United States | Montefiore Einstein Center for Cancer Care | Bronx | New York |
| United States | Bryn Mawr Skin & Cancer Institute | Bryn Mawr | Pennsylvania |
| United States | Oncology Specialists of Charlotte | Charlotte | North Carolina |
| United States | Northwestern University Department of Dermatology | Chicago | Illinois |
| United States | Ohio State University | Columbus | Ohio |
| United States | Compassionate Cancer Care | Fountain Valley | California |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Washington University | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Veloce BioPharma LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |