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Completed

NCT Number: NCT01783353

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

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.

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Key information

Conditions

Recalcitrant Cutaneous Warts DNA Virus Infections Infections Papillomavirus Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases Warts

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Philippine General Hospital

Manila, NCR, 1000, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non-pregnant female
  • Age 19 years and older
  • With ≥ one (1) recalcitrant common, mosaic, palmar, plantar, or periungual wart/s
  • Consent given

Exclusion criteria

  • Current or history of mental illness
  • Current or history of malignancy
  • Severe immunodeficiency states
  • Pregnant or lactating
  • Documented adverse effects to oral or topical zinc exposure
  • Oral intake of zinc supplements in the past 12 months or less
  • Oral Intake of H2 antagonists in the past 4 weeks or less
  • Oral intake of immunosuppressives in the past 4 weeks or less
  • Concurrent usage of other treatment modalities
  • Current anogenital warts

Treatment and study plan

Zinc gluconate

Dietary Supplement

Corn starch pill

Dietary Supplement

Primary outcomes

  1. Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60

    Time frame: 60 days

Secondary outcomes

  1. Types of adverse events

    Time frame: 60 days

    Types and severity of adverse events will be noted on Day 30 (+5 days) and Day 60 (+5 days) by the primary investigator by verbally asking the subjects and by physically examining them

  2. Severity of adverse events

    Time frame: 60 days

    Types and severity of adverse events will be noted on Day 30 (+5 days) and Day 60 (+5 days) by the primary investigator by verbally asking the subjects and by physically examining them. Severity will be based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events by the National Institute Of Allergy And Infectious Diseases. For abnormalities not found in the DAIDS Toxicity Tables, the following scale will be used to estimate grade:

    • Grade 1, Mild: No limitation in activity; no medical intervention/therapy required
    • Grade 2, Moderate: Mild to moderate limitation in activity; no or minimal medical intervention required
    • Grade 3, Severe: Marked limitation in activity; medical intervention required; hospitalization possible
    • Grade 4, Life-Threatening: Extreme limitation in activity; significant medical intervention required; hospitalization or hospice care probable

  3. Recurrence

    Time frame: 120 days

    The recurrence rate in patients who achieve complete response to zinc will be assessed at Day 120 or two months after discontinuation of zinc intake.

Sponsors and collaborators

Lead sponsor

Philippine Dermatological Society

Network

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2013
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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