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| Name | Class |
|---|---|
| Women's Health Services, Santa Fe, New Mexico | OTHER |
| Southwest College of Naturopathic Medicine | OTHER |
| Beth Israel Medical Center | OTHER |
| Matrixx Initiatives, Inc. |
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Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc gluconate | Active Comparator | Oral swabs containing homeopathic Zinc gluconate |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zicam (Ionic zinc) | Drug | 33mmol/l of ionic zinc |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S Riley, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steven Messer ND, DHANP | Tempe | Arizona | 85282 | United States | ||
| Deborah Thompson, MD MSPH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11347285 | Background | 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. |
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Subjects were excluded if they had HSL for more than one day
Subjects were recruited at 3 medical clinics: Women's Health Services, Santa Fe, NM; Continuum Center, NYC, NY; SCNM medical Clinic, Scottsdale, Az
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Active medication - Zinc Swabs |
| FG001 | Placebo Treatment | Placebo medication - Swabs identical to medication group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Active medication - Zinc Swabs |
| BG001 | Placebo Treatment | Placebo medication - Swabs identical to medication group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 5 subjects met exclusion criteria and were excluded from analysis. 2 subjects used concomitant medications and were excluded from the final analysis. Twelve subjects with recurrent HSL enrolled twice, only the 1st enrollment was included in the analysis. 2 subjects had family enroll who were excluded from analysis. Analysis - 134 subjects. | Posted | Median | 95% Confidence Interval | Days to resolution | 14 days |
|
14 days per subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | Active medication - Zinc Swabs |
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There may have been differences between the populations in the different study sites that influenced the outcome of this clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Riley, MD | Integrative Medicine Institute | 505 690-0688 | dsriley@integrativemed.org |
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| ID | Term |
|---|---|
| D006560 | Herpes Labialis |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| INDUSTRY |
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| placebo | Drug | placebo swab |
|
|
| Santa Fe |
| New Mexico |
| 87501 |
| United States |
| Benjamin Kligler, MD | New York | New York | 10016 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Active medication - Zinc Swabs
| OG001 | Placebo Treatment | Placebo medication - Swabs identical to medication group |
|
|
| Secondary | Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions. | Not Posted | 14 days |
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Placebo Treatment | Placebo medication - Swabs identical to medication group | 0 | 79 | 0 | 79 |
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| D007239 |
| Infections |
| D017193 | Skin Diseases, Viral |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |