Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Study Overview
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Brief Summary
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Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.

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.

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

Conditions
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Herpes Simplex Labialis

Intervention / Treatment
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* Drug: Zicam (Ionic zinc)
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zinc gluconate<br>Oral swabs containing homeopathic Zinc gluconate | Drug: Zicam (Ionic zinc)<br>* 33mmol/l of ionic zinc<br>* Other names: Homeopathic Zinc gluconate;|
| Placebo Comparator: Placebo<br>placebo | Drug: placebo<br>* placebo swab<br>* Other names: placebo swab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions. |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cold sores, Zinc, HSL, Herpes simple labialis