- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01783353
Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
NCR
-
Manila, NCR, Philippines, 1000
- Philippine General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Corn starch pill
Two (2) corn starch pills will be taken three (3) times a day for 60 days.
|
|
Experimental: Zinc gluconate
Two (2) zinc gluconate 50 mg capsules will be taken three (3) times a day for 60 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Types of adverse events
Time Frame: 60 days
|
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
Time Frame: 60 days
|
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:
|
60 days
|
Recurrence
Time Frame: 120 days
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rochelle L. Castillo, M.D., Philippine General Hospital Section of Dermatology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDS_PGH_2013_001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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