Clinical trial NCT00809809: Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-Center Trial of Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Simplex Labialis
Keywords: Cold sores
Zinc
HSL
Herpes simple labialis
Lead sponsor: Integrative Medicine Institute
Sponsor class: OTHER
Collaborators: name: Women's Health Services, Santa Fe, New Mexico
name: Southwest College of Naturopathic Medicine
name: Beth Israel Medical Center
name: Matrixx Initiatives, Inc.
First posted: 2008-12-17
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: 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.
timeFrame: 14 days
Secondary outcomes:
measure: Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.
timeFrame: 14 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Steven Messer ND, DHANP
state: Arizona
city: Santa Fe
country: United States
facility: Deborah Thompson, MD MSPH
state: New Mexico
city: New York
country: United States
facility: Benjamin Kligler, MD
state: New York
Study officials:
affiliation: University of New Mexico
name: David S Riley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.