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
Primary Purpose
Chemotherapy-Associated Paronychia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VBP-926
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-Associated Paronychia
Eligibility Criteria
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
Sites / Locations
- Compassionate Cancer Care
- Northwestern University Department of Dermatology
- Washington University
- Montefiore Einstein Center for Cancer Care
- Memorial Sloan Kettering Cancer Center
- Oncology Specialists of Charlotte
- Ohio State University
- Bryn Mawr Skin & Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Lower concentration VBP-926
Higher concentration VBP-926
Vehicle
Arm Description
VBP-926 solution applied to affected area BID
VBP-926 solution applied to affected area BID
Vehicle solution applied to affected area BID
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03207906
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
July 17, 2018 (Actual)
Study Completion Date
September 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veloce BioPharma LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Associated Paronychia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lower concentration VBP-926
Arm Type
Active Comparator
Arm Description
VBP-926 solution applied to affected area BID
Arm Title
Higher concentration VBP-926
Arm Type
Active Comparator
Arm Description
VBP-926 solution applied to affected area BID
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle solution applied to affected area BID
Intervention Type
Drug
Intervention Name(s)
VBP-926
Intervention Description
Topical VBP-926 solution
Primary Outcome Measure Information:
Title
Downgrading of the 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) in adult cancer patients with chemotherapy-associated paronychia
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayashri Krishnan, PhD
Organizational Affiliation
JSS Research
Official's Role
Study Director
Facility Information:
Facility Name
Compassionate Cancer Care
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Montefiore Einstein Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Oncology Specialists of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Bryn Mawr Skin & Cancer Institute
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31240513
Citation
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.
Results Reference
derived
Learn more about this trial
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
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