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Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Primary Purpose

Herpes Simplex Labialis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zicam (Ionic zinc)
placebo
Sponsored by
Integrative Medicine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex Labialis focused on measuring Cold sores, Zinc, HSL, Herpes simple labialis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Steven Messer ND, DHANP
  • Deborah Thompson, MD MSPH
  • Benjamin Kligler, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zinc gluconate

Placebo

Arm Description

Oral swabs containing homeopathic Zinc gluconate

placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.

Full Information

First Posted
December 15, 2008
Last Updated
November 19, 2013
Sponsor
Integrative Medicine Institute
Collaborators
Women's Health Services, Santa Fe, New Mexico, Southwest College of Naturopathic Medicine, Beth Israel Medical Center, Matrixx Initiatives, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00809809
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrative Medicine Institute
Collaborators
Women's Health Services, Santa Fe, New Mexico, Southwest College of Naturopathic Medicine, Beth Israel Medical Center, Matrixx Initiatives, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex Labialis
Keywords
Cold sores, Zinc, HSL, Herpes simple labialis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc gluconate
Arm Type
Active Comparator
Arm Description
Oral swabs containing homeopathic Zinc gluconate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Zicam (Ionic zinc)
Other Intervention Name(s)
Homeopathic Zinc gluconate
Intervention Description
33mmol/l of ionic zinc
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
placebo swab
Intervention Description
placebo swab
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Riley, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steven Messer ND, DHANP
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Deborah Thompson, MD MSPH
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87501
Country
United States
Facility Name
Benjamin Kligler, MD
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11347285
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.
Results Reference
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Learn more about this trial

Zinc for the Treatment of Herpes Simplex Labialis (HSL)

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