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

  • PHASE II STUDIES
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Summary

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://clinicaltrials.gov/ct2/show/NCT03207906

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Funding

This work was supported by Veloce BioPharma. M. Lacouture is funded, in part, through the NIH/NCI Cancer Center Support Grant P30 CA008748. B. Kaffenberger is a recipient of the Dermatology Foundation Career Development Award.

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Authors and Affiliations

  1. Veloce BioPharma LLC, Fort Lauderdale, FL, USA

    Kara D. Capriotti & Samuel Barone

  2. Bryn Mawr Skin and Cancer Institute, 919 Conestoga Road, Building 2, Suite 106, Rosemont, PA, 19010, USA

    Kara D. Capriotti

  3. Department of Medicine, Division of Dermatology, Washington University School of Medicine, Saint Louis, MO, USA

    Milan Anadkat

  4. Department of Dermatology, Ohio State University Dermatology, Columbus, OH, USA

    Jennifer Choi

  5. Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Benjamin Kaffenberger

  6. Department of Medicine, Division of Dermatology, Albert Einstein College of Medicine, Bronx, NY, USA

    Beth McLellan

  7. Department of Medicine, Dermatology Service, New York, NY, USA

    Oluwaseun Kukoyi, Shari Goldfarb & Mario Lacouture

  8. Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Oluwaseun Kukoyi, Shari Goldfarb & Mario Lacouture

Authors
  1. Kara D. Capriotti
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  7. Oluwaseun Kukoyi
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  9. Mario Lacouture
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Corresponding author

Correspondence to Kara D. Capriotti.

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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.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Capriotti, K.D., Anadkat, M., Choi, J. et al. 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 37, 1247–1256 (2019). https://doi.org/10.1007/s10637-019-00825-0

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