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

NCT03207906 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2017-VBP-926
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Chemotherapy-Associated Paronychia

Outcome Measures

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.

  8 weeks

Study Arms (3)

Lower concentration VBP-926

ACTIVE COMPARATOR

VBP-926 solution applied to affected area BID

Drug: VBP-926

Higher concentration VBP-926

ACTIVE COMPARATOR

VBP-926 solution applied to affected area BID

Drug: VBP-926

Vehicle

PLACEBO COMPARATOR

Vehicle solution applied to affected area BID

Drug: VBP-926

Interventions

VBP-926 DRUG

Topical VBP-926 solution

Higher concentration VBP-926; Lower concentration VBP-926; Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Veloce BioPharma LLC: lead

Study Sites (8)

Compassionate Cancer Care

Fountain Valley, California, 92708, United States

Location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10022, United States

Location

Montefiore Einstein Center for Cancer Care

The Bronx, New York, 10461, United States

Location

Oncology Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

Bryn Mawr Skin & Cancer Institute

Bryn Mawr, Pennsylvania, 19010, United States

Location

Related Publications (1)

• 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.

  PMID: 31240513 DERIVED

Study Officials

• Jayashri Krishnan, PhD

  JSS Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 5, 2017
• Study Start: October 24, 2017
• Primary Completion: July 17, 2018
• Study Completion: September 18, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)