Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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Zinc salts irreversibly inhibit herpes virus replication in vitro and are effective in treating herpes infections in vivo and have been shown in a clinical trial to be a effective topical treatment for HSL. Zinc salt solutions applied to herpetic lesions decrease viral load and markedly improve healing rates, relieving the symptoms of herpes as healing occurs. Zinc swabs contain 33 mmol/l of ionic Zinc in an emulsification of Benzalkonium chloride, glycerin, hydroxyethylcellulose, sodium chloride, and sodium hydroxide (ph 7.2). Zinc gluconate is monographed in the Homeopathic Pharmacopoeia of the United States (HPUS) and one of OTC indications for Zinc and its salts is for the treatment of cold sores.

Conditions

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Herpes Simplex Labialis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zinc gluconate

Oral swabs containing homeopathic Zinc gluconate

Group Type ACTIVE_COMPARATOR

Zicam (Ionic zinc)

Intervention Type DRUG

33mmol/l of ionic zinc

Placebo

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo swab

Interventions

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Zicam (Ionic zinc)

33mmol/l of ionic zinc

Intervention Type DRUG

placebo

placebo swab

Intervention Type DRUG

Other Intervention Names

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Homeopathic Zinc gluconate placebo swab

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No