A Phase II Study of an Iodine-Based Solution (VBP-926) to Treat Nail Problems Caused by Chemotherapy

Full Title

2017-VBP-926: A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Phase-2 Trial to Evaluate the Efficacy and Safety of Two Concentrations of Topical Povidone-Iodine Nail Solution (VBP-926) for the Treatment of Chemotherapy-Associated Paronychia in Cancer Patients

Purpose

Chemotherapy for cancer can cause inflammation and infection of the nails called paronychia. There is no FDA-approved treatment for this condition. In this study, researchers are evaluating the safety and effectiveness of an investigational nail solution called VBP-926 to treat chemotherapy-related nail problems. VBP-926 kills microorganisms (such as bacteria, viruses, yeasts, molds, fungi, and protozoa) which may cause paronychia.

Patients in this study will be randomly assigned to receive one of two concentrations of the VBP-926-containing nail solution or a placebo (an inactive nail solution that does not contain VBP-926). The solution is applied to each nail using a medicine dropper.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have paronychia (redness, swelling, and infection around the nail) related to cancer treatment.
  • This study is for patients age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Mario Lacouture at 646-888-6014.

Protocol

17-633

Phase

II

Investigator

Co-Investigators

Diseases