Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Herpes Simplex Labialis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multi-Center Trial of Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809809
• Other study ID #: IMIZnc2008
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2008
• Last updated: November 19, 2013
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: November 2013
• Source: Integrative Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Labialis
• Herpes Simplex
• Herpes Simplex Labialis

Intervention

Drug:
• Zicam (Ionic zinc)
33mmol/l of ionic zinc
• placebo
placebo swab

Locations

Country	Name	City	State
United States	Benjamin Kligler, MD	New York	New York
United States	Deborah Thompson, MD MSPH	Santa Fe	New Mexico
United States	Steven Messer ND, DHANP	Tempe	Arizona

Sponsors (5)

Lead Sponsor	Collaborator
Integrative Medicine Institute	Beth Israel Medical Center, Matrixx Initiatives, Inc., Southwest College of Naturopathic Medicine, Women's Health Services, Santa Fe, New Mexico

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	14 days	No
Secondary	Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.		14 days	Yes