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.

Study Overview

• Status: Completed
• Conditions: Recalcitrant Cutaneous Warts
• Intervention / Treatment: Dietary supplement: Corn starch pill; Dietary supplement: Zinc gluconate

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Philippines
  • NCR
    • Manila, NCR, Philippines, 1000
      • Philippine General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Current or history of mental illness
2. Current or history of malignancy
3. Severe immunodeficiency states
4. Pregnant or lactating
5. Documented adverse effects to oral or topical zinc exposure
6. Oral intake of zinc supplements in the past 12 months or less
7. Oral Intake of H2 antagonists in the past 4 weeks or less
8. Oral intake of immunosuppressives in the past 4 weeks or less
9. Concurrent usage of other treatment modalities
10. Current anogenital warts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Corn starch pill; Two (2) corn starch pills will be taken three (3) times a day for 60 days.	Dietary supplement: Corn starch pill
Experimental: Zinc gluconate; Two (2) zinc gluconate 50 mg capsules will be taken three (3) times a day for 60 days.	Dietary supplement: Zinc gluconate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types of adverse events	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	60 days
Severity of adverse events	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	60 days
Recurrence	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.	120 days

Collaborators and Investigators

• Sponsor: Philippine Dermatological Society
• Investigators: Principal Investigator: Rochelle L. Castillo, M.D., Philippine General Hospital Section of Dermatology

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 30, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): November 14, 2013
• Last Update Submitted That Met QC Criteria: November 13, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Recalcitrant cutaneous warts; verruca
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: PDS_PGH_2013_001