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Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial

NCT01783353 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2013-11-14

No results posted yet for this study

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.

Conditions

  • Recalcitrant Cutaneous Warts

Interventions

DIETARY_SUPPLEMENT

Zinc gluconate

DIETARY_SUPPLEMENT

Corn starch pill

Sponsors & Collaborators

  • Philippine Dermatological Society

    lead NETWORK

Principal Investigators

  • Rochelle L. Castillo, M.D. · Philippine General Hospital Section of Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01783353 on ClinicalTrials.gov