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

Veloce BioPharma

Status and phase: Completed; Phase 2

Conditions: Chemotherapy-Associated Paronychia

Treatments: Drug: VBP-926

Study type: Interventional

Funder types: Industry

Identifiers

NCT03207906

2017-VBP-926

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 3 patient groups, including a placebo group

Lower concentration VBP-926

Active Comparator group

Description:

VBP-926 solution applied to affected area BID

Treatment:

Drug: VBP-926

Higher concentration VBP-926

Active Comparator group

Description:

VBP-926 solution applied to affected area BID

Treatment:

Drug: VBP-926

Vehicle

Placebo Comparator group

Description:

Vehicle solution applied to affected area BID

Treatment:

Drug: VBP-926