Herpes Simplex Labialis
Conditions
Keywords
Cold sores, Zinc, HSL, Herpes simple labialis
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.
Interventions
DRUGZicam (Ionic zinc)
33mmol/l of ionic zinc
DRUGplacebo
placebo swab
Sponsors
Women's Health Services, Santa Fe, New Mexico
Southwest College of Naturopathic Medicine
Beth Israel Medical Center
Matrixx Initiatives, Inc.
Integrative Medicine Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 14 days | 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
| Measure | Time frame |
|---|---|
| Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions. | 14 days |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at 3 medical clinics: Women's Health Services, Santa Fe, NM; Continuum Center, NYC, NY; SCNM medical Clinic, Scottsdale, Az
Pre-assignment details
Subjects were excluded if they had HSL for more than one day
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment Active medication - Zinc Swabs | 78 |
| Placebo Treatment Placebo medication - Swabs identical to medication group | 79 |
| Total | 157 |
Baseline characteristics
| Characteristic | Placebo Treatment | Active Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants | 78 Participants | 157 Participants |
| Age, Continuous | 43.8 years STANDARD_DEVIATION 12.5 | 42.6 years STANDARD_DEVIATION 11.8 | 43.1 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 79 participants | 78 participants | 157 participants |
| Sex: Female, Male Female | 62 Participants | 60 Participants | 122 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 78 | 0 / 79 |
| serious Total, serious adverse events | 0 / 78 | 0 / 79 |
Outcome results
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.
Time frame: 14 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Treatment | 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. | 8 Days to resolution |
| Placebo Treatment | 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. | 6 Days to resolution |
Secondary
Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.
Time frame: 14 days