A randomised controlled proof‐of‐concept trial of digoxin and furosemide in adults with cutaneous warts

Summary

Background

Topical Ionic Contra‐Viral Therapy (ICVT) comprised of digoxin and furosemide inhibits the potassium influx on which DNA viruses rely for replication. Therefore, ICVT was hypothesised to be a potential novel treatment for cutaneous warts.

Objectives

To assess clinical efficacy, safety and tolerability of ICVT in adults with cutaneous warts. Secondary objective was to gain insight into underlying working mechanism of ICVT.

Methods

Treatment with ICVT was assessed for efficacy, safety and tolerability in a single‐ centre, randomised, double‐blind, placebo‐controlled phase 2A trial. Eighty adult subjects with at least 2 cutaneous warts (plantar or common) were randomised to one of 4 treatments: digoxin + furosemide (0.125%), digoxin (0.125%), furosemide (0.125%) or placebo and administered the gel once daily for 42 consecutive days. Pre‐defined statistical analysis was performed with a mixed model analysis of covariance.

Results

Wart size and HPV load reduction was achieved in all active treatment groups. A statistically significant reduction in wart diameter of all treated warts was shown in the digoxin + furosemide treatment group versus placebo (‐3.0mm; 95% CI ‐4.9 to ‐1.1mm; p=0.002). There was a statistically significant reduction in HPV load of all treated warts in the digoxin + furosemide group compared to placebo (‐94%; 95% CI ‐100 to ‐19; p=0.03). With wart size reduction, histologically and immunohistochemically defined viral characteristics disappeared from partial and total responding warts.

Conclusions

This study demonstrates proof‐of‐concept for the efficacy of topical ICVT in adults with cutaneous warts.

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