Brief Summary
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.
Brief Title
A Trial to Evaluate the Efficacy and Safety of Two Concentrations of VBP-926 Solution for the Treatment of Chemotherapy-associated Paronychia in Cancer Patients
Completion Date
Completion Date Type
Actual
Conditions
Chemotherapy-Associated Paronychia
Eligibility Criteria
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
* 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
Inclusion Criteria
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)
* 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)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03207906
Org Class
Industry
Org Full Name
Veloce BioPharma LLC
Org Study Id
2017-VBP-926
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Downgrading of the 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) in adult cancer patients with chemotherapy-associated paronychia
Outcome Time Frame
8 weeks
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Beth Mclellan
Investigator Email
bmclella@montefiore.org
Investigator Phone
718-862-8840