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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chemotherapy-Associated Paronychia

Intervention / Treatment
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* Drug: VBP-926


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lower concentration VBP-926<br>VBP-926 solution applied to affected area BID | Drug: VBP-926<br>* Topical VBP-926 solution<br>|
| Active Comparator: Higher concentration VBP-926<br>VBP-926 solution applied to affected area BID | Drug: VBP-926<br>* Topical VBP-926 solution<br>|
| Placebo Comparator: Vehicle<br>Vehicle solution applied to affected area BID | Drug: VBP-926<br>* Topical VBP-926 solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |