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.
Recalcitrant Cutaneous Warts
Dietary Supplement: Zinc gluconate
Dietary Supplement: Corn starch pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial|
- 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 ] [ Designated as safety issue: No ]
- Types of adverse events [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]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 of adverse events [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
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
- Recurrence [ Time Frame: 120 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2013|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783353
|Philippine General Hospital|
|Manila, NCR, Philippines, 1000|
|Principal Investigator:||Rochelle L. Castillo, M.D.||Philippine General Hospital Section of Dermatology|