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


Phase 2/Phase 3
19 Years
N/A
Open (Enrolling)
Both
Recalcitrant Cutaneous Warts

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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

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