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Nail Fungus

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Nail Fungus

General Purpose:

In basic terms, nail fungus refers to a fungal infection in one or more of the fingernails or toenails. It can start out as a white or yellow spot and then lead to thickening and discoloration of the nail and nail bed as it spreads. This can cause both pain and embarrassment for those who are affected.

Unfortunately, nail fungus can often be difficult to treat effectively, and it can often recur following successful treatment. Although various yeasts and molds can lead to the development of a fungal nail infection, the most often culprit is a fungi from the dermatophyte group.

Older individuals are at a greater risk for fungal infections in their nails, due to decreased blood circulation, cumulative lifetime exposure to fungi, and age-related decline in the growth of nails (which makes them more susceptible to infections). Apart from age, men are more likely to be affected than women.

Furthermore, moisture and humidity promote the growth of fungus, therefore walking barefoot in bathrooms and locker rooms, working in humid environments, and wearing socks that do not offer adequate ventilation can also increase the risk of fungal infections. Additionally, diabetes, psoriasis and certain immune diseases can also increase an individual’s risk of developing a fungal nail infection.

Fortunately, research is ongoing to determine more effective methods of preventing and treating fungal nail infections, as well as researching the problem from a cosmetic aspect in order to improve the appearance of affected fingers and toes.

What Will Nail Fungus Clinical Trials Be Like?

The types of procedures used in nail fungus clinical trials will ultimately depend on the specific nature of the study, the type of fungi being studied, and the specific aspect(s) of the associated symptoms. Provided below is a list of common procedures, tests, and assessments that may be incorporated into fungal skin infection clinical trials:

  • Detailed physical examination
  • Nail biopsy for microscopic analysis
  • Blood tests
  • Use of lotions, creams, oral medications, or laser light therapy
  • Photography of the fingernails

Typical Nail Fungus Clinical Trial Protocol:

Specific examples of clinical trials for nail fungus might include the following:

  • A clinical trial to determine if a topical anti-fungal cream, applied once a day for four weeks to the affected nail(s) is effective and safe at treating fungal nail infections in diabetic men.
  • A randomized clinical trial in which a standard oral antifungal therapy plus a new topical antifungal medication is collectively more effective at treating severe fungal nail infections when compared to standard oral antifungal therapy plus a placebo topical medication.
  • A study to determine if laser light therapy is a safe and effective means of treating fungal nail infections. In such a study, patients would be randomly assigned to receive either treatment with the laser light or a “placebo” treatment during which laser light therapy is simulated but not actively delivered.  

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 second 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 (such as the third study example above), the investigational treatment might be compared to a placebo alone. 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, including the type of fungal nail infection you have. 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:

  • The location of your infection (i.e., which nails) and the type of fungal infection you have (if known)
  • 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:

 “nail fungus treatment,” “nail fungus prevention,” “nail fungus adolescent,” “nail fungus hygiene,” “nail fungus diabetes,” “nail fungus elderly,” “nail fungus age,” “nail fungus medication,” and “nail fungus complications.”

Current Search Term:

“Nail Fungus”

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