Zinc for the Treatment of Herpes Simplex Labialis (HSL)

This study is currently recruiting participants.

Verified by Integrative Medicine Institute, December 2008

Sponsors and Collaborators:	Integrative Medicine Institute Women's Health Services, Santa Fe, NM Southwest College of Naturopathic Medicine Beth Israel Continuum Center for Health and Healing, New York, NY Matrixx Initiative, Inc.
Information provided by:	Integrative Medicine Institute
ClinicalTrials.gov Identifier:	NCT00809809

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 III

MedlinePlus related topics: Herpes Simplex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Further study details as provided by Integrative Medicine Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	106
Study Start Date:	December 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Zinc	Drug: Zicam (Ionic zinc) 33mmol/l of ionic zinc
2: Placebo Comparator placebo	Drug: placebo 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

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

Contacts

Contact: David S Riley, MD	5059830546	dsriley@integrativemed.org
Contact: Katherine Hostettler	5052310531	kahcalling@earthlink.net

Locations

United States, Arizona
Steven Messer ND, DHANP	Not yet recruiting
Tempe, Arizona, United States, 85282
Contact: Steven Messer, ND, DHANP 480-222-9240 s.messer@scnm.edu
United States, New Mexico
Deborah Thompson, MD MSPH	Recruiting
Santa Fe, New Mexico, United States, 87501
Contact: Katie Chavez-Cook, RN 505-988-8869 kchavezcook@wssf.org
United States, New York
Benjamin Kligler, MD	Not yet recruiting
New York, New York, United States, 10016
Contact: Benjamin Kligler, MD 646-935-2251 bkligler@chpnet.org

Sponsors and Collaborators

Integrative Medicine Institute

Women's Health Services, Santa Fe, NM

Southwest College of Naturopathic Medicine

Beth Israel Continuum Center for Health and Healing, New York, NY

Matrixx Initiative, Inc.

More Information

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.

Responsible Party:	Integrative Medicine Institute ( David Riley, MD )
Study ID Numbers:	IMIZnc2008
Study First Received:	December 15, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809809
Health Authority:	United States: Institutional Review Board

Keywords provided by Integrative Medicine Institute:

Cold sores
Zinc
HSL
Herpes simple labialis

Study placed in the following topic categories:

Mouth Diseases
Virus Diseases
Herpes Simplex
Skin Diseases, Infectious
Skin Diseases

Zinc
DNA Virus Infections
Stomatognathic Diseases
Herpesviridae Infections
Herpes Labialis

Additional relevant MeSH terms:

Skin Diseases, Viral
Growth Substances
Physiological Effects of Drugs
Trace Elements

Micronutrients
Lip Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009