Recalcitrant Cutaneous Warts Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Philippines | Philippine General Hospital | Manila | NCR |
| Lead Sponsor | Collaborator |
|---|---|
| Philippine Dermatological Society |
Philippines,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60 | 60 days | No | |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | No |