Clinical trial NCT03207906: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-Associated Paronychia
Lead sponsor: Veloce BioPharma LLC
Sponsor class: INDUSTRY
First posted: 2017-07-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Downgrading of the 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) in adult cancer patients with chemotherapy-associated paronychia
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care
state: California
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Bronx
country: United States
facility: Montefiore Einstein Center for Cancer Care
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Oncology Specialists of Charlotte
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Bryn Mawr
country: United States
facility: Bryn Mawr Skin & Cancer Institute
state: Pennsylvania
Study officials:
affiliation: JSS Research
name: Jayashri Krishnan, PhD
role: STUDY_DIRECTOR
References:
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.