NCT00809809 is a Phase 3 clinical trial of Zicam (Ionic zinc) in Herpes Simplex Labialis, sponsored by Integrative Medicine Institute.

Who is sponsoring NCT00809809?

NCT00809809 is sponsored by Integrative Medicine Institute.

What drugs are being tested in NCT00809809?

Interventions in NCT00809809: Zicam (Ionic zinc), placebo.

What condition does NCT00809809 study?

NCT00809809 studies Herpes Simplex Labialis.

Is NCT00809809 still recruiting?

NCT00809809 is currently completed. Last updated 19 November 2013.

Are results published for NCT00809809?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-11-19 · How we verify

NCT00809809

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-blind, Placebo-controlled, Multi-Center Trial of Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Completed Phase 3 Results posted Last updated 19 November 2013

What this trial tests

Phase 3 trial testing Zicam (Ionic zinc) in Herpes Simplex Labialis in 157 participants. Completed in 1 December 2010.

Timeline

1 December 2008

Primary endpoint
1 September 2009

1 December 2010

Quick facts

Lead sponsor	Integrative Medicine Institute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	157
Start date	1 December 2008
Primary completion	1 September 2009
Estimated completion	1 December 2010
Sites	3 locations across United States

Drugs / interventions tested

Zicam (Ionic zinc) — full drug profile →
placebo

Conditions studied

Herpes Simplex Labialis — all drugs for Herpes Simplex Labialis →

Sponsor

Integrative Medicine Institute

Who can join

Adults 18 to 65, any sex, with Herpes Simplex Labialis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Zicam Was Compared to Placebo as a Treatment of Recurrent HSL From the Date and Time of the Initiation of Therapy Until the Date and Time of Resolution of the Lesion or After 14 Days of Treatment, Whichever Comes First.
Time frame: 14 days
Zinc gluconate swabs were compared as a treatment of recurrent HSL compared to placebo from the date and time of the initiation of therapy until the date and time of resolution of the lesion or after 14 days of treatment, whichever comes first.

Sponsor's own description

Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00809809 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Integrative Medicine Institute
Last refreshed: 19 November 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00809809.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing