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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

Tracking Information
First Submitted Date  ICMJE December 15, 2008
First Posted Date  ICMJE December 17, 2008
Results First Submitted Date  ICMJE March 21, 2012
Results First Posted Date  ICMJE January 8, 2014
Last Update Posted Date January 8, 2014
Study Start Date  ICMJE December 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
Evaluate the effectiveness of Zicam 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. [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions. [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
Evaluate the effectiveness of Zicam to increase the incidence of, and speed of, the rate of healing, for aborted cold sore lesions. [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multi-Center Trial of Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Brief Summary Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Herpes Simplex Labialis
Intervention  ICMJE
  • Drug: Zicam (Ionic zinc)
    33mmol/l of ionic zinc
    Other Name: Homeopathic Zinc gluconate
  • Drug: placebo
    placebo swab
    Other Name: placebo swab
Study Arms  ICMJE
  • Active Comparator: Zinc gluconate
    Oral swabs containing homeopathic Zinc gluconate
    Intervention: Drug: Zicam (Ionic zinc)
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: placebo
Publications * Godfrey HR, Godfrey NJ, Godfrey JC, Riley D. A randomized clinical trial on the treatment of oral herpes with topical zinc oxide/glycine. Altern Ther Health Med. 2001 May-Jun;7(3):49-56.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2013)
157
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
106
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809809
Other Study ID Numbers  ICMJE IMIZnc2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Integrative Medicine Institute
Study Sponsor  ICMJE Integrative Medicine Institute
Collaborators  ICMJE
  • Women's Health Services, Santa Fe, New Mexico
  • Southwest College of Naturopathic Medicine
  • Beth Israel Medical Center
  • Matrixx Initiatives, Inc.
Investigators  ICMJE
Principal Investigator: David S Riley, MD University of New Mexico
PRS Account Integrative Medicine Institute
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP