Trial Information
Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60
Outcome Time Frame:
60 days
Safety Issue:
No
Principal Investigator
Rochelle L. Castillo, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Philippine General Hospital Section of Dermatology
Authority:
Philippines : Food and Drug Administration
Study ID:
PDS_PGH_2013_001
NCT ID:
NCT01783353
Start Date:
January 2013
Completion Date:
Related Keywords:
- Recalcitrant Cutaneous Warts
- Recalcitrant cutaneous warts
- verruca
- Warts