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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-24

Study Completion Date

2018-09-18

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.

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Detailed Description

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Conditions

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Chemotherapy-Associated Paronychia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Lower concentration VBP-926

VBP-926 solution applied to affected area BID

Group Type ACTIVE_COMPARATOR

VBP-926

Intervention Type DRUG

Topical VBP-926 solution

Higher concentration VBP-926

VBP-926 solution applied to affected area BID

Group Type ACTIVE_COMPARATOR

VBP-926

Intervention Type DRUG

Topical VBP-926 solution

Vehicle

Vehicle solution applied to affected area BID

Group Type PLACEBO_COMPARATOR

VBP-926

Intervention Type DRUG

Topical VBP-926 solution

Interventions

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VBP-926

Topical VBP-926 solution

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No