Phase 3 N=157 Randomized Quadruple-blind Treatment

Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Herpes Simplex Labialis

Bottom Line

View on ClinicalTrials.gov: NCT00809809 ↗

Enrolled (actual)

157

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcome: Primary: 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. — 8; 6 Days to resolution

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Zicam (Ionic zinc) (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Integrative Medicine Institute
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	8; 6	—
SECONDARY Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.	—	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Subjects with a history of HSL with at least 2 episodes/year for the past two years that have proceeded beyond the prodromal (initial) stage
Male or female subjects between 18 and 65 years of age
Symptoms or signs of HSL for less than one day (max. 36 hours from onset of symptoms to first visit)
Confirmation of HSL by a clinician at the study site
Willing to comply with study instructions and sign an informed consent

Exclusion Criteria

HSL symptoms or signs for more than one day
Cold sore outbreak within the past 2 weeks
Previous participation in this clinical trial
Topical or oral antiviral drug use in the past 1 week
Immune deficiency (HIV positive), chronic steroid therapy, present anti-neoplastic or radiation therapy, Hodgkin's disease, splenectomy, leukemia, myeloma, lymphoma, or another condition/drug per judgment of attending health care professional) or currently taking immune suppressive drugs. Previous organ or bone marrow transplant.
Pregnancy or lactation
Unable to travel to the clinic area for the required visits
Apparent inability to understand or follow the instructions associated with the clinical study
History of adverse events to the study material or facial cosmetics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00809809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.