Status:
COMPLETED
Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Lead Sponsor:
Integrative Medicine Institute
Collaborating Sponsors:
Women's Health Services, Santa Fe, New Mexico
Southwest College of Naturopathic Medicine
Conditions:
Herpes Simplex Labialis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00809809
Start Date
December 1 2008
End Date
December 1 2010
Last Update
January 8 2014
Active Locations (3)
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1
Steven Messer ND, DHANP
Tempe, Arizona, United States, 85282
2
Deborah Thompson, MD MSPH
Santa Fe, New Mexico, United States, 87501
3
Benjamin Kligler, MD
New York, New York, United States, 10016