Herpes Simplex LabialisPhase 3NCT00809809
Zinc for the Treatment of Herpes Simplex Labialis (HSL)
A Phase 3 study testing Zicam (Ionic zinc) in people with Herpes Simplex Labialis, run by Integrative Medicine Institute at 3 sites in United States.
Trial summary
Evaluate the effectiveness of a topical preparation of zinc to treat cold sores. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Herpes Simplex Labialis
- What is being tested?
- Zicam (Ionic zinc)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2008to Dec 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Benjamin Kligler, MD
New York, New York, 10016
Deborah Thompson, MD MSPH
Santa Fe, New Mexico, 87501
Steven Messer ND, DHANP
Tempe, Arizona, 85282
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-Center Trial of Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.
Read the 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.
- Conditions
- Herpes Simplex Labialis
- Being tested
- Zicam (Ionic zinc), placebo
- Keywords
- Cold sores, Zinc, HSL, Herpes simple labialis
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zicam (Ionic zinc)Drug
Also called Homeopathic Zinc gluconate
33mmol/l of ionic zinc
placeboDrug
Also called placebo swab
placebo swab
| Study group | Role | What they receive |
|---|---|---|
| Zinc gluconate | Active comparator | Oral swabs containing homeopathic Zinc gluconate Receives: Drug: Zicam (Ionic zinc) |
| Placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes Simplex LabialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Health Services, Santa Fe, New Mexico, Southwest College of Naturopathic Medicine, Beth Israel Medical Center, Matrixx Initiatives, Inc.
- Responsible party
- Sponsor
- Investigators
- David S Riley, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809809
- Sponsor's protocol ID
- IMIZnc2008
- Status last verified
- Nov 2013
- First submitted
- 15 Dec 2008
- Last updated
- 8 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 11347285
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-Center Trial of Zinc for the Treatment of Herpes Simplex Labialis (HSL)
- ClinicalTrials.gov ID
- NCT00809809
- Acronym / sponsor ID
- IMIZnc2008
- Conditions
- Herpes Simplex Labialis
- Keywords
- Cold sores, Zinc, HSL, Herpes simple labialis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Integrative Medicine InstituteUniversity, hospital or other
- Collaborators
- Women's Health Services, Santa Fe, New Mexico, Southwest College of Naturopathic Medicine, Beth Israel Medical Center, Matrixx Initiatives, Inc.
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 8 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc gluconate | Active comparator | Drug: Zicam (Ionic zinc)Oral swabs containing homeopathic Zinc gluconate |
| Placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zicam (Ionic zinc)Also: Homeopathic Zinc gluconate33mmol/l of ionic zinc | Drug | Zinc gluconate |
| placeboAlso: placebo swabplacebo swab | Drug | Placebo |
Primary outcome
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.
Time frame: 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.
1 secondary outcome
Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11347285Godfrey 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.
Related trials for Herpes Simplex Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Riley, MD principal investigator
University of New Mexico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zicam (Ionic zinc) in people with Herpes Simplex Labialis, run by Integrative Medicine Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2014.