Clinical Trial: Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 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.
Sponsor: Integrative Medicine Institute

Current Primary Outcome: 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: 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 ]

Current Secondary Outcome: 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: 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 ]

Information By: Integrative Medicine Institute

Dates:
Date Received: December 15, 2008
Date Started: December 2008
Date Completion:
Last Updated: November 19, 2013
Last Verified: November 2013