Expired Study
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Santa Fe, New Mexico 87501


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00809809


Primary Contact:

David S Riley, MD
Phone: 5059830546
Email: dsriley@integrativemed.org


Backup Contact:

Email: kahcalling@earthlink.net
Katherine Hostettler
Phone: 5052310531


Location Contact:

Santa Fe, New Mexico 87501
United States

Katie Chavez-Cook, RN
Phone: 505-988-8869
Email: kchavezcook@wssf.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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