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Background: Local hyperthermia has been demonstrated to be a safe and efficacious treatment for warts. Objective: We aimed to evaluate the safety and efficacy of an epicutaneous heat patch to induce local hyperthermia for the treatment of warts. Methods: We performed an uncontrolled, proof of concept study by applying a novel, reproducible, epicutaneous heat patch to a target wart for 2 hours per day for 12 weeks. There were 15 evaluable participants. An untreated wart was also observed and measured. Wart measurements included the diameter in two dimensions, an investigator global assessment (IGA) score, wart clearance, and monitoring for adverse events as endpoints at week 12 (end of treatment) and week 24 (end of study). Results: No major adverse events were observed. 6.7% of participants reported minor cutaneous events. At week 24, 46.7% of participants achieved complete clearance of both warts. Limitations: The small sample size and lack of independent control in each participant were the main limiting factors. Conclusion: Local hyperthermia delivered by epicutaneous heat patches was well-tolerated, safe, and achieved complete clearance in both treated as well untreated warts in 46.7% of participants at week 24 after 12 weeks of daily use. Clinicaltrials.gov: NCT01746056 J Drugs Dermatol. 2019;18(4):368-373.

Prior studies have identified local heat therapy as a treatment for recalcitrant warts. We have employed a thermal pad that raises local temperature to 42-43ºC for at least 2 hours in a proof of concept study of three patients with recalcitrant warts. The recalcitrant warts cleared in all three patients beginning in the fourth and fifth weeks after daily treatment with the pads. There were no adverse events. We conclude that the timing of clearance following use of these thermal pads is likely via direct viral killing and immunologic mechanisms. Further controlled trials are underway.