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


Phase 4
19 Years
N/A
Not Enrolling
Both
Genital Warts, HPV

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Trial Information

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


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.


Inclusion Criteria:



1. Adults age 19 and over

2. Clinical diagnosis of genital warts requiring treatment based on clinician evaluation

3. Fluency in English

4. Available within four days of the intended 8 week follow-up visit

Exclusion Criteria:

1. Individuals under the age of 19

2. Pregnant women

3. Known contraindication to zinc Signs of copper/iron deficiency which include anemia
and neutropenia which are characterized by tiredness, fatigue and light headedness.

4. Diseases that alter zinc metabolism or absorption eg. type II diabetes mellitus,
Crohn's disease, chronic leg ulcers

5. Clients who are currently taking zinc for therapeutic purposes or have taken zinc in
the last two months for therapeutic purposes

6. Clients who have received standard of care treatment for their warts in the past
month

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

complete clearance of genital warts

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Richard Lester

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia

Authority:

Canada:None required

Study ID:

Oral Zinc RTC

NCT ID:

NCT01468636

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Genital Warts
  • HPV
  • Warts
  • HPV
  • Zinc
  • Condylomata Acuminata
  • Warts

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