See If You May Qualify

• By participating in a type of research study called a clinical trial, you may have access to an investigational product for prurigo nodularis (PN).
• Participation in clinical trials benefits others with PN by helping researchers learn about new options.
• Talk with your dermatologist to decide whether a clinical trial may be right for you.

Clinical trials may represent an opportunity to access specialist care while improving scientific knowledge about prurigo nodularis. For decades, scientists have used these types of research studies to learn about investigational treatments.

MyPrurigoTeam spoke with Dr. Shawn Kwatra, associate professor of dermatology and director of the Johns Hopkins Itch Center in Baltimore, Maryland, about the importance of clinical studies for PN. Dr. Kwatra treats people with PN and leads research to better understand this chronic skin condition.

Many factors are involved in the decision to join a research study. Here’s some information about how clinical trials work and why you might want to consider signing up.

See If You May Qualify

Clinical Trial Basics

Clinical trials are designed by researchers to help them better understand and treat a specific disease. They aim to answer questions about a disease such as: What causes it? Can it be prevented? Are there better ways to diagnose and treat it? Trials may test the effects of lifestyle changes, medications, or other therapies. If you join a clinical trial, health care providers will work with you to understand whether you'll continue your current treatment plan, stop treatment for a while, or switch to an investigational product.

Safety and Privacy Protection

The FDA regulates clinical trials to ensure a quality scientific process and to prioritize the safety and well-being of participants. Researchers must provide participants with clear and accurate information about the study to ensure informed consent before enrollment. Informed consent means that you agree to participate after fully understanding the implications and risks of the study. During the informed consent process, participants learn about what the study involves and are given the chance to ask questions. If you join a clinical trial, you have the right to leave at any point.

In addition, a committee called an institutional review board (IRB) is responsible for providing ethical oversight for a clinical trial from its design all the way through the study. This committee is typically made up of doctors, researchers, and a nonscientific member of the public who live with the condition. The IRB reviews the informed consent documents and evaluates the study protocol to help safeguard participant welfare.

Reasons To Consider Joining a Clinical Trial

There are many reasons to sign up for a clinical trial for PN, and everyone has their own reasons for choosing to do so.

Taking an Active Role in Your Healthcare

PN is far less prevalent than other types of inflammatory skin conditions. For example, 2 percent to 10 percent of adults have atopic dermatitis (eczema), and 2 percent to 3 percent have psoriasis. But only 0.1 percent of adults are diagnosed with PN, and characteristics of the disease can affect individuals differently. If you think you have PN, talk to your dermatologist.

To qualify for a clinical trial, you’ll need to meet specific eligibility criteria. You’ll be seen by PN experts who are aware of the latest research. You may need to undergo screenings to ensure that you have PN and be evaluated for other factors and medical conditions that could impact your suitability to be included in the study.

Accessing Investigational Agents

Clinical trials can provide an opportunity to potentially try agents that are being investigated, different dosages, or combinations of drugs before they are approved by the FDA. Your participation in a clinical trial may provide doctors with knowledge about how to improve outcomes for you and others living with PN in the future.

Clinical studies may assess whether the investigational or existing drug, dosage, combination of drugs, or other intervention can provide improvement of prurigo nodularis symptoms. If you qualify for a clinical trial, you can participate without additional costs to you.

Ongoing Studies

Examples of therapies currently being studied in clinical trials for PN include a class of oral drugs called opioid modulators, and monoclonal antibodies, biologic drugs that are taken by injection. Depending on the specifics of the study, clinical trial drugs may be used in combination with other therapies that you find helpful, such as corticosteroids or phototherapy, a form of therapy using UV light.

Additionally, some research studies don’t focus on drugs but on other interventions that may improve quality of life or help manage side effects of treatment. This might include dietary changes or mental health counseling, for example. If your current prurigo nodularis treatment is effective but you struggle with side effects or other quality-of-life issues, there may be a trial aimed at addressing your needs.

Clinical trials have potential risks as well as potential benefits. You'll be informed about any potential risks during the process of obtaining informed consent, before deciding whether to join a study. You'll also have the chance to discuss any risks with your doctor.

Receiving Care From a Specialized Team

Participants in clinical trials typically undergo more testing and assessments than people who aren’t in trials. This close medical supervision helps researchers monitor the effectiveness of the treatment and any potential side effects. If you find it reassuring to have heightened supervision of your condition, participating in a research study may appeal to you.

Helping Others

No matter what happens in a clinical trial, everyone who participates leaves a lasting legacy of contributing to medical knowledge that may benefit countless others. If helping others brings you a sense of purpose and comfort, that’s another reason to consider participating in a clinical trial.

Talk to Your Doctor About Clinical Trials

Since your PN specialist has detailed knowledge of your condition, they’re the best person to help you understand your options for deciding whether you’ll benefit from joining a clinical trial.

“If a person is considering a clinical trial, it’s important that patients keep in close contact with their dermatologist, and discuss the pros and cons of participating in a clinical trial,” summed up Dr. Kwatra.

See If You May Qualify

Get Support From Others Who Understand

On MyPrurigoTeam, a social network for people with prurigo nodularis and their loved ones, members come together to ask questions, give advice, and share their stories with others who understand life with prurigo nodularis.

Have you participated in a clinical trial? Share your experience in the comments below, or start a conversation by posting on your Activities page.