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

Study Overview
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Brief Summary
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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.

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

Conditions
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Recalcitrant Cutaneous Warts

Intervention / Treatment
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* Dietary Supplement: Zinc gluconate
* Dietary Supplement: Corn starch pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recalcitrant cutaneous warts, verruca