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Zinc for the Treatment of Herpes Simplex Labialis (HSL)

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ClinicalTrials.gov Identifier: NCT00809809
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Collaborators:
Women's Health Services, Santa Fe, New Mexico
Southwest College of Naturopathic Medicine
Beth Israel Medical Center
Matrixx Initiatives, Inc.
Information provided by (Responsible Party):
Integrative Medicine Institute

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

Condition or disease Intervention/treatment Phase
Herpes Simplex Labialis Drug: Zicam (Ionic zinc) Drug: placebo Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-Center Trial of Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Study Start Date : December 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Zinc gluconate
Oral swabs containing homeopathic Zinc gluconate
 Drug: Zicam (Ionic zinc)
33mmol/l of ionic zinc
Other Name: Homeopathic Zinc gluconate
Placebo Comparator: Placebo
placebo
 Drug: placebo
placebo swab
Other Name: placebo swab


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions. [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809809


Locations
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United States, Arizona
Steven Messer ND, DHANP
Tempe, Arizona, United States, 85282
United States, New Mexico
Deborah Thompson, MD MSPH
Santa Fe, New Mexico, United States, 87501
United States, New York
Benjamin Kligler, MD
New York, New York, United States, 10016
Sponsors and Collaborators
Integrative Medicine Institute
Women's Health Services, Santa Fe, New Mexico
Southwest College of Naturopathic Medicine
Beth Israel Medical Center
Matrixx Initiatives, Inc.
Investigators
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Principal Investigator: David S Riley, MD University of New Mexico
More Information
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Publications:

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Responsible Party: Integrative Medicine Institute
ClinicalTrials.gov Identifier: NCT00809809    
Other Study ID Numbers: IMIZnc2008
First Posted: December 17, 2008    Key Record Dates
Results First Posted: January 8, 2014
Last Update Posted: January 8, 2014
Last Verified: November 2013
Keywords provided by Integrative Medicine Institute:
Cold sores
Zinc
HSL
Herpes simple labialis
Additional relevant MeSH terms:
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Herpes Simplex
Herpes Labialis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Skin Diseases, Viral
Skin Diseases, Infectious
 Skin Diseases
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Zinc
Trace Elements
Micronutrients
Physiological Effects of Drugs