Zinc for the Treatment of Herpes Simplex Labialis (HSL)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Integrative Medicine Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Integrative Medicine Institute
Collaborators:
Women's Health Services, Santa Fe, New Mexico
Southwest College of Naturopathic Medicine
Beth Israel Medical Center
Matrixx Initiatives, Inc.
Information provided by:
Integrative Medicine Institute
ClinicalTrials.gov Identifier:
NCT00809809
First received: December 15, 2008
Last updated: December 16, 2008
Last verified: December 2008
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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:
- 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 |
|---|---|
|
Active Comparator: 1
Zinc
|
Drug: Zicam (Ionic zinc)
33mmol/l of ionic zinc
|
|
Placebo Comparator: 2
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, New Mexico
Southwest College of Naturopathic Medicine
Beth Israel Medical Center
Matrixx Initiatives, Inc.
More Information
Publications:
| Responsible Party: | David Riley, MD, Integrative Medicine Institute |
| ClinicalTrials.gov Identifier: | NCT00809809 History of Changes |
| Other Study ID Numbers: | IMIZnc2008 |
| Study First Received: | December 15, 2008 |
| Last Updated: | December 16, 2008 |
| 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 Simplex Herpes Labialis Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Lip Diseases Mouth Diseases Stomatognathic Diseases |
Skin Diseases, Infectious Skin Diseases Zinc Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013