NCT00809809

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 8, 2014

Completed
Last Updated

January 8, 2014

Status Verified

November 1, 2013

Enrollment Period

9 months

First QC Date

December 15, 2008

Results QC Date

March 21, 2012

Last Update Submit

November 19, 2013

Conditions

Herpes Simplex Labialis

Keywords

Cold soresZincHSLHerpes simple labialis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    14 days

Study Arms (2)

Zinc gluconate

ACTIVE COMPARATOR

Oral swabs containing homeopathic Zinc gluconate

Drug: Zicam (Ionic zinc)

Placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Zicam (Ionic zinc)DRUG

33mmol/l of ionic zinc

Also known as: Homeopathic Zinc gluconate
Zinc gluconate
placeboDRUG

placebo swab

Also known as: placebo swab
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Steven Messer ND, DHANP

Tempe, Arizona, 85282, United States

Location

Deborah Thompson, MD MSPH

Santa Fe, New Mexico, 87501, United States

Location

Benjamin Kligler, MD

New York, New York, 10016, United States

Location

Related 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.

    PMID: 11347285BACKGROUND

MeSH Terms

Conditions

Herpes Labialis

Condition Hierarchy (Ancestors)

Herpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralLip DiseasesMouth DiseasesStomatognathic DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

There may have been differences between the populations in the different study sites that influenced the outcome of this clinical trial.

Results Point of Contact

Title
David Riley, MD
Organization
Integrative Medicine Institute
dsriley@integrativemed.org
505 690-0688

Study Officials

  • David S Riley, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 17, 2008

Study Start

December 1, 2008

Primary Completion

September 1, 2009

Study Completion

December 1, 2010

Last Updated

January 8, 2014

Results First Posted

January 8, 2014

Record last verified: 2013-11

Locations

US(3)