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

January 23, 2019 updated by: Veloce BioPharma LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Care
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Dermatology
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Einstein Center for Cancer Care
      • New York, New York, United States, 10022
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Oncology Specialists of Charlotte
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Ohio State University
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Skin & Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veloce BioPharma LLC

Investigators

  • Study Director: Jayashri Krishnan, PhD, JSS Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2017

Primary Completion (Actual)

July 17, 2018

Study Completion (Actual)

September 18, 2018

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-VBP-926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemotherapy-Associated Paronychia

Clinical Trials on VBP-926

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe