A Randomized Phase 2 Trial of the Efficacy and Safety of a Novel Topical Povidone-Iodine Formulation for Cancer Therapy-Associated Paronychia
| Autor: | Milan J. Anadkat, Benjamin Kaffenberger, Beth N. McLellan, Oluwaseun Kukoyi, Samuel Barone, Jennifer N. Choi, Kara Capriotti, Mario E. Lacouture, Shari Goldfarb |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Male medicine.medical_specialty Phases of clinical research Antineoplastic Agents Severity of Illness Index Article 03 medical and health sciences 0302 clinical medicine Quality of life Double-Blind Method Internal medicine Neoplasms Clinical endpoint medicine Humans Pharmacology (medical) Dosing Adverse effect Paronychia Povidone-Iodine Pharmacology business.industry Cancer Middle Aged medicine.disease 030104 developmental biology Treatment Outcome Oncology 030220 oncology & carcinogenesis Cohort Quality of Life Female business |
| Zdroj: | Invest New Drugs |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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