NCT01468636

A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts

A Randomized Controlled Trial to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effect of 400 mg of oral zinc gluconate on genital warts. Our hypothesis is that there will be a 10% difference in complete clearance of genital warts in the group randomized to oral plus standard of care compared to those randomized to placebo plus standard of care.

Detailed description

Clients presenting to the BCCDC STI clinic with genital warts will be randomized to either 400 mg zinc gluconate or placebo (200mg BID) for 8 weeks in addition to the standard of care. Clinical assessment of warts and additional standard treatment will occur every 7-10 days for a maximum of 8 weeks. A telephone call will occur at week 20 to determine if any of the warts have cleared or re-appeared. The appearance of new warts will also be noted. The proportion of subjects who have complete clearance of genital warts at 8 weeks will be compared between groups.

Conditions

• Genital Warts
• HPV

Interventions

Type	Name	Description
DRUG	Oral Zinc	200 mg BID of oral zinc gluconate x 8 weeks
DRUG	Placebo	200mg BID x 8 weeks

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-11-09
• Last updated: 2016-11-02

Locations

1 site across 1 country: Canada