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

Sponsor

Veloce BioPharma LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03207906

Collaborator

(none)

102

Enrollment

Locations

Arms

10.8

Actual Duration (Months)

12.8

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-Associated Paronychia	Drug: VBP-926	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 24, 2017

Actual Primary Completion Date :

Jul 17, 2018

Actual Study Completion Date :

Sep 18, 2018

Arms and Interventions

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

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

Outcome Measures

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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Compassionate Cancer Care	Fountain Valley	California	United States	92708
2	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611
3	Washington University	Saint Louis	Missouri	United States	63130
4	Montefiore Einstein Center for Cancer Care	Bronx	New York	United States	10461
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10022
6	Oncology Specialists of Charlotte	Charlotte	North Carolina	United States	28207
7	Ohio State University	Columbus	Ohio	United States	43221
8	Bryn Mawr Skin & Cancer Institute	Bryn Mawr	Pennsylvania	United States	19010

Sponsors and Collaborators

Veloce BioPharma LLC

Investigators

Study Director: Jayashri Krishnan, PhD, JSS Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Veloce BioPharma LLC

ClinicalTrials.gov Identifier:

NCT03207906

Other Study ID Numbers:

2017-VBP-926

First Posted:

Jul 5, 2017

Last Update Posted:

Jan 25, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Paronychia

Study Results

No Results Posted as of Jan 25, 2019