A randomized phase 2 trial of the efficacy and safety of a novel topical povidone-iodine formulation for Cancer therapy-associated Paronychia

Abstract

Purpose Cancer therapy-associated paronychia (CAP) is a frequent adverse event associated with cytotoxic and targeted therapies that may impact dosing of anticancer therapies and patient quality of life (QoL). There are currently no evidence-based management strategies or approved treatments for CAP. Materials and Methods This was a prospective, multicenter, randomized, double-blind, vehicle-controlled phase 2 study that evaluated the efficacy and safety of 6 to 8 weeks of 1% or 2% povidone-iodine (PVP-I) topical solution versus vehicle-control in adult patients with CAP. Patients were randomized to one of three treatment arms administered twice daily: 1% PVP-I (Cohort A), 2% PVP-I (Cohort B), or vehicle-control (Cohort C). The primary endpoint was a two-grade reduction (or reduction to grade 0 if involved nails were grade 1) on the six-point Paronychia Severity Grading (PSG) scale. Secondary endpoints included safety and the effect on QoL and microbiota. Results A total of 102 patients with cancer were randomized to the study. In Cohort A, 83 of 205 (40.5%, P = 0.6059) affected nails met the primary endpoint versus Cohort C. In Cohort B, 88 of 167 (52.7%, P = 0.0063) affected nails met the primary endpoint versus 64 of 169 (37.9%) in Cohort C. Nineteen of 29 patients (65.5%) in Cohort B reported moderately or very painful nails at baseline that decreased to 15 patients (51.7%) at visit 2 and five patients (17.2%) at visit 3. Conclusions Treatment with twice-daily topical 2% PVP-I was safe and resulted in improvement in CAP compared with control. Clinicaltrials.gov identifier: NCT03207906. https://ichgcp.net/clinical-trials-registry/NCT03207906.

Keywords: Anticancer; Paronychia; Povidone-iodine; Quality of life; Toxicity.

Conflict of interest statement

Conflict of Interest

K. Capriotti owns equity and is an employee of Veloce BioPharma. M. Anadkat has received honoraria for consulting and/or speaking engagements in the past from Adgero, Astra Zeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Biogen, Eli Lilly, Genentech, ImClone, Therakos, Xoma, and Eisai and has also served as a Principal Investigator for Biogen, Veloce BioPharma, Xoma, Hana Biosciences, and InflamRx. J. Choi declares that she has no conflict of interest. B. Kaffenberger is an Investigator for Biogen, Celgene, Eli Lilly Co, and Veloce BioPharma. B. McLellan has served as an investigator for Veloce BioPharma. S. Barone owns equity and is an employee of Veloce BioPharma. All other authors have declared no relevant conflicts of interest. O. Kukoyi declares that he has no conflict of interest. S. Goldfarb declares that she has no conflict of interest. M. Lacouture has a consultant/speaking role with Legacy Healthcare Services, Adgero Bio Pharmaceuticals, Amryt Pharmaceuticals, Celldex Therapeutics, Debiopharm, Galderma Research and Development, Johnson and Johnson, Novocure Inc, Lindi, Merck Sharp and Dohme Corporation, Helsinn Healthcare SA, Janssen Research & Development LLC, Menlo Therapeutics, Novartis Pharmaceuticals Corporation, F. Hoffmann-La Roche AG, AbbVie Inc, Boehringer Ingelheim Pharma Gmbh & Co. KG, Allergan Inc, Amgen Inc, E.R. Squibb & Sons LLC, EMD Serono Inc, AstraZeneca Pharmaceuticals LP, Genentech Inc, Leo Pharma Inc, Seattle Genetics, Bayer, Manner SAS, Lutris, Pierre Fabre, Paxman Coolers, Adjucare, Dignitana, Biotechspert, Teva Mexico, Parexel, OnQuality Pharmaceuticals Ltd, Oncoderm, Apricity, Novartis, and Our Brain Bank. Dr. Lacouture also receives research funding from Berg, Bristol-Myers Squibb, Lutris, Paxman, Novocure, US Biotest, and Veloce BioPharma.

Figures

Figure 1.

Paronychia Quality of Life Questionnaire

Figure 2.

CONSORT Diagram

Figure 3.

Percentage of nails with a two-grade reduction (or reduction to zero if nails involved are only grade 1) in each treatment group. (P = 0.0063 [95% CI] 2% PVP-I vs. vehicle-control)

Figure 4.

Patient in Cohort B at baseline (top) and visit 3 (bottom) 6–8 weeks later with a two-grade reduction on the Paronychia Severity Scale.

Figure 5.

Percentage of pain free nails at baseline, visit 2 (2–4 weeks) and visit 3 (6–8 weeks). (P = 0.1338 [95% CI] 2% PVP-I vs. control at visit 3)