CClinicalTrials.gg
CompletedNCT03207906Updated Jan 25, 2019

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

A Phase 2 interventional study of VBP-926 in Chemotherapy-Associated Paronychia, sponsored by Veloce BioPharma LLC. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by Veloce BioPharma LLC · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2018, 8 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chemotherapy-Associated Paronychia
03

In context

Lead sponsor

Veloce BioPharma LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Active comparator
    Lower concentration VBP-926

    VBP-926 solution applied to affected area BID

    Drug: VBP-926

  • Active comparator
    Higher concentration VBP-926

    VBP-926 solution applied to affected area BID

    Drug: VBP-926

  • Placebo comparator
    Vehicle

    Vehicle solution applied to affected area BID

    Drug: VBP-926

Interventions

  • DrugVBP-926

    Topical VBP-926 solution

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

07

Study locations

8 sites
  • Compassionate Cancer Care
    Fountain Valley, California 92708, United States
  • Northwestern University Department of Dermatology
    Chicago, Illinois 60611, United States
  • Washington University
    Saint Louis, Missouri 63130, United States
  • Montefiore Einstein Center for Cancer Care
    Bronx, New York 10461, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10022, United States
  • Oncology Specialists of Charlotte
    Charlotte, North Carolina 28207, United States
  • Ohio State University
    Columbus, Ohio 43221, United States
  • Bryn Mawr Skin & Cancer Institute
    Bryn Mawr, Pennsylvania 19010, United States
08

References and documents

Publications

  • Capriotti KD, Anadkat M, Choi J, Kaffenberger B, McLellan B, Barone S, Kukoyi O, Goldfarb S, Lacouture M. A randomized phase 2 trial of the efficacy and safety of a novel topical povidone-iodine formulation for Cancer therapy-associated Paronychia. Invest New Drugs. 2019 Dec;37(6):1247-1256. doi: 10.1007/s10637-019-00825-0. Epub 2019 Jun 26. PubMed 31240513 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03207906
Lead sponsor
Veloce BioPharma LLC
Responsible party
Sponsor
First posted
Jul 5, 2017
Start date
Oct 24, 2017
Primary completion
Jul 17, 2018
Completion
Sep 18, 2018
Last update
Jan 25, 2019

Study contacts

Jayashri Krishnan, PhD
study director · JSS Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion