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Clinical Trial Summary

Up to one-third of common warts can remain recalcitrant, an occurrence that has been attributed to impaired cell-mediated immunity. At present, no guidelines exist for the management of recalcitrant cutaneous warts. Zinc, a well-established immunomodulatory agent, has shown promise in this regard. Previous studies documenting the efficacy of oral zinc used zinc sulfate given at a maximum dose of 600 mg/day, equivalent to 140 mg of elemental zinc, which is over three times the recommended upper limit of 40 mg of elemental zinc per day. This raises concerns over safety and tolerability. In the Philippines, oral zinc is more widely available in chelated forms such as zinc gluconate, which have the benefit of improved absorption compared to non-chelated compounds such as zinc sulfate. This study will seek to determine if zinc gluconate 300 mg/day, equivalent to 40 mg of elemental zinc, will be efficacious in treating recalcitrant cutaneous warts. This lowered dose may have the added benefits of increased safety, tolerability, and cost-effectiveness.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01783353
Study type Interventional
Source Philippine Dermatological Society
Contact
Status Completed
Phase Phase 2/Phase 3
Start date January 2013
Completion date September 2013