Shingles

About Shingles Clinical Trials (Click to Open)

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Shingles

General Purpose:

Shingles is the common term used to refer to a painful rash caused by the varicella-zoster virus, which is the same virus that causes chickenpox. This virus is part of the herpes group of viruses (which cause genital herpes and cold sores), therefore it is sometimes referred to as herpes zoster.

Following a case of the chickenpox, the virus lies dormant in the body; however, it can eventually become reactive and cause shingles to develop. Shingles has a very characteristic appearance, typically occurring as a single stripe of blisters that wraps around the torso, though the rash can also occur around an eye or on one side of the neck or face.

It can cause severe pain, burning, and numbness, as well as itching. The blisters can also break open and create a crust on the surface of the affected areas of the skin. In addition, it can be accompanied by fever, achiness, headache, and fatigue.

If left untreated, shingles that occurs near the eye can lead to permanent eye damage. Individuals over age 65 are at an increased risk of complications for shingles, as are those who have a weakened immune system. Complications include residual nerve pain, vision loss, facial paralysis, hearing or balance problems, and skin infections. 

Unfortunately there is no cure for shingles but quick treatment with anti-viral medicines can help to promote healing and reduce the risk of complications down the road. The good news is that researchers are hard at work searching for new and improved methods to treat shingles and its associated complications.

What Will Shingles Clinical Trials Be Like?

The types of procedures used in shingles clinical trials will ultimately depend on the specific nature of the study and what aspect related to shingles 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
  • Questionnaires to evaluate your stress level, pain level, emotional well-being, and history of current and former illnesses.
  • Blood tests
  • Biopsy of shingles blisters
  • Photographs of your blisters
  • Use of lotions, creams, oral medications, or laser light therapy

Typical Shingles Clinical Trial Protocol:

Specific examples of clinical trials for shingles might include the following:

  • A randomized clinical trial in which patients with shingles are randomly assigned to receive treatment with standard antiviral therapy using acyclovir plus placebo, or a newly-developed antiviral medication.
  • A study to determine the safety and efficacy of an anti-shingles vaccine administered to elderly individuals.
  • A study to determine in individuals with shingles experience, improved pain control when relaxation techniques are incorporated into a comprehensive pain management plan that includes medication.
  • A randomized clinical trial to evaluate the safety and efficacy of a new pain medication in the treatment of shingles-related pain. In such a study, patients would randomly be assigned to receive standard therapy for shingles-related pain plus the new medication, or standard therapy for shingles-related pain plus a placebo.

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 (such as the fourth clinical trial example provided above). 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 chickenpox and shingles
  • 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:

 “shingles treatment,” “shingles prevention,” “shingles pregnancy,” “shingles recurrence,” “shingles complications,” “shingles children,” “shingles stress,” “shingles elderly,” “shingles pain,” and “shingles vaccine.”

 

Current Search Term:

“Shingles”

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