Frequently Asked Questions

 

Frequently Asked Questions about this Trial:

What is this trial about?
Why is this trial being done?
How large is this trial?
Who can participate in this trial?
What are my costs to participate in this trial?
How long will this trial last?

 

Frequently Asked Questions about Clinical Trials:

Who can participate in a research study?
What happens during a research study?
What should people consider before participating in a study?
Does a participant continue to work with a primary health care provider while in a study?
What are side effects and adverse reactions?
How is the safety of the participant protected?
Can a participant leave a research study after it has begun?

 

What is this trial about?

This clinical research study looking at the safety and efficacy of an investigational medication for a particular type of toenail fungus called distal subungual onychomycosis, or “DSO”. A clinical research study is a medical study designed to answer important questions about a potential new medication (called an investigational medication), such as whether it improves a patient’s health or causes any side effects.
 

Why is this trial being done?

Researchers are investigating how well symptoms and disease activity are reduced in patients applying an investigational medication.
 

How large is this trial?

The trial will be conducted at approximately 25 research sites. About 300 patients with mild to moderate DSO will participate.
 

Who can participate in this trial?

You may be able to participate in this trial if you:

• Have the toenail fungus called distal subungual onychomycosis or “DSO”

• Are between 18 and 75 years of age

• There are additional qualifications that will be discussed with you by the study coordinator at the clinic
 

What are my costs to participate in this trial?

There is no cost to you or your insurance provider for participating in this trial. You will receive all study-related care and investigational drug at no cost.
 

How long will this trial last?

This trial lasts about 1 year and includes 7 visits to the research clinic.
 

Who can participate in a research study?

All research studies have guidelines about who can participate. Using inclusion/exclusion criteria is an important part of medical research that helps to produce reliable results. The factors that allow someone to participate in a research study are called "inclusion criteria". The factors that disallow someone from participating are called "exclusion criteria". These criteria are based on factors like age, gender, the type and stage of a disease, and other medical conditions. Inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants for the study. The criteria help ensure that researchers will be able to answer the questions they plan to study.
 

What happens during a research study?

The process depends on the kind of study being conducted. The research study team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the study, give specific instructions for participating in the study, monitor the participant during the study, and stay in touch after the study is completed.

Some research studies involve more tests and doctor visits than someone would normally have for an illness or condition. For all types of studies, the participant works with a research team.
 

What should people consider before participating in a study?

Answers to these questions from a study’s health care team may be helpful in making your decision:

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental drug being tested may be effective? Has it been tested before?
  • What kinds of tests and experimental drugs are involved?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How might this study affect my daily life?
  • How long will the study last?
  • Will hospitalization be required?
  • Who will pay for the experimental drugs?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How will I know that the experimental drug is working? Will results of the studies be provided to me?
  • Who will be in charge of my care?
     

Does a participant continue to work with a primary health care provider while in a study?

Yes. Most research studies are short-term and do not provide extended or complete primary health care.
 

What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the experimental drug or treatment. General examples of negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects.

There are risks to research studies.

-  There may be unpleasant, serious or even life-threatening side effects to experimental drugs.

-  The experimental drugs may not be effective for the participant.

-  The study may require more time and attention than a non-study treatment, including trips to the research study site, more treatments, hospital stays or complex dosage requirements.
 

How is the participant protected?

The ethical and legal codes that govern medical practice also apply to research studies. In addition, most research is federally regulated with built-in safeguards to protect the participants. The study follows a controlled protocol, a study plan which details what researchers will do in the study. As a research study progresses, researchers report the results of the study at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
 

Can a participant leave a research study after it has begun?

Yes. A participant can leave a research study, at any time. When withdrawing from the study, the participant should let the research team know about it, in order to safely withdraw from the study.