Zinc for the Treatment of Herpes Simplex Labialis (HSL)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00809809
First received: December 15, 2008
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Herpes Simplex Labialis
Drug: Zicam (Ionic zinc)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Integrative Medicine Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 157
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809809

Locations
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
Principal Investigator: David S Riley, MD University of New Mexico
  More Information

Publications:
Responsible Party: Integrative Medicine Institute
ClinicalTrials.gov Identifier: NCT00809809     History of Changes
Other Study ID Numbers: IMIZnc2008
Study First Received: December 15, 2008
Results First Received: March 21, 2012
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Integrative Medicine Institute:
Cold sores
Zinc
HSL
Herpes simple labialis

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
DNA Virus Infections
Herpesviridae Infections
Lip Diseases
Mouth Diseases
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Stomatognathic Diseases
Virus Diseases
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 29, 2014