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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rochelle L. Castillo, Philippine Dermatological Society
ClinicalTrials.gov Identifier:
NCT01783353
First received: January 30, 2013
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Recalcitrant Cutaneous Warts
Dietary Supplement: Zinc gluconate
Dietary Supplement: Corn starch pill
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Philippine Dermatological Society:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 28
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783353

Locations
Philippines
Philippine General Hospital
Manila, NCR, Philippines, 1000
Sponsors and Collaborators
Philippine Dermatological Society
Investigators
Principal Investigator: Rochelle L. Castillo, M.D. Philippine General Hospital Section of Dermatology
  More Information

No publications provided

Responsible Party: Rochelle L. Castillo, M.D., Philippine Dermatological Society
ClinicalTrials.gov Identifier: NCT01783353     History of Changes
Other Study ID Numbers: PDS_PGH_2013_001
Study First Received: January 30, 2013
Last Updated: November 13, 2013
Health Authority: Philippines : Food and Drug Administration

Keywords provided by Philippine Dermatological Society:
Recalcitrant cutaneous warts
verruca

Additional relevant MeSH terms:
Warts
DNA Virus Infections
Neoplasms
Papillomavirus Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Tumor Virus Infections
Virus Diseases
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 25, 2014