Cold Sores

About Cold Sores Clinical Trials (Click to Open)

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Cold Sores

General Purpose:

Cold sores, or fever blisters, are small fluid-filled lesions that occur on and around the mouth, in particular the area of the lips. They are spread between individuals through close contact, such as kissing or sharing drinks. They tend to cluster in small groups and once they break, are covered in a thin crust.

Fortunately, they do not last long and typically heal completely within two weeks of appearing. Cold sores are caused by a virus known as herpes simplex virus (HSV-1), which is a close cousin of the virus that leads to the formation of genital herpes (HSV-2). There is no cure for the virus that causes cold sores, therefore current research is focused on developing new anti-viral medications that decrease the healing time for cold sores and reduce the frequency of their recurrence.

What Will Cold Sore Clinical Trials Be Like?

The types of procedures used in cold sore clinical trials will ultimately depend on the specific nature of the study and what aspect related to cold sores is being studied. Provided below is a list of common procedures, tests, and assessments that may be incorporated into such clinical trials:

  • Detailed physical examination
  • A questionnaire or face-to-face interview to provide details related to your history of cold sores, which may include questions related to the following:
    • Date you first experienced a cold sore
    • Use of cosmetic and personal hygiene products
    • Your current and prior history of sexual activity
    • Use of prescription or over-the-counter medications, including vitamins, minerals, and other dietary supplements
    • Treatments you have attempted to use for your cold sores
    • Questionnaires to evaluate your stress level and/or emotional well-being
    • Blood tests
    • Biopsy of existing cold sores
    • Photographs of your cold sores
    • Use of lotions, creams, oral medications, or laser light therapy

Typical Cold Sore Clinical Trial Protocol:

Specific examples of clinical trials for cold sores might include the following:

  • A randomized clinical trial in which patients with active cold sores are randomly assigned to receive treatment with standard antiviral therapy using acyclovir plus placebo, or a newly-developed antiviral medication.
  • A randomized clinical trial in which individuals with active cold sores are randomly assigned to receive treatment with a new drug containing high amounts of the mineral zinc, or a placebo.
  • A randomized study in which individuals with a history of cold sores are treated with long-term low-dose antiviral therapy over the course of a year, during which they are assessed at regular four week intervals to determine the frequency of recurrence. In such a study, a separate group of individuals would be randomly assigned to not receive the long-term antiviral therapy but would also be followed at regular intervals to determine the frequently of their recurrence. At the conclusion of this study, the two groups of patients would be compared to determine if those who received the low-dose long-term antiviral therapy experienced fewer recurrences of their cold sores than those in the control group.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as the first clinical trial example described above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed: 

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • Your history of cold sores
  • Your prior and current diagnoses of any other health conditions or diseases
  • Your current medications (including vitamins, minerals, and other dietary supplements)

Suggested Search Terms:

“cold sores treatment,” “cold sores prevention,” “cold sores recurrence,” “cold sores children,” and “cold sores stress.”

Current Search Term:

“Cold Sores”

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Conditions:   Herpes Labialis;   Cold Sore
Interventions:   Drug: SADBE;   Other: Placebo
Sponsor:   Squarex, LLC
Recruiting - verified February 2017


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Condition:   Herpes Labialis
Interventions:   Drug: Pritelivir 5% w/w ointment;   Drug: Pritelivir ointment matching placebo;   Drug: Zovirax® cream
Sponsors:   AiCuris Anti-infective Cures GmbH;   Novella Clinical
Recruiting - verified February 2017


Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis


Condition:   Herpes Labialis
Interventions:   Other: BOR15001L7;   Other: Placebo
Sponsor:   Laboratoire Boreaderme Inc.
Recruiting - verified March 2017


Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis


Condition:   Herpes Labialis
Interventions:   Drug: Acyclovir 5 percent (Perrigo);   Drug: Acyclovir 5 percent (Reference);   Drug: Placebo cream
Sponsor:   Perrigo Company
Completed - verified June 2016


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Condition:   Herpes Labialis
Intervention:   Drug: valacyclovir
Sponsor:   GlaxoSmithKline
Completed - verified December 2016


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Condition:   Herpes Simplex
Intervention:   Drug: Valaciclovir
Sponsor:   GlaxoSmithKline
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