Prurigo nodularis (PN) is a skin condition that causes continued itching and can be hard to treat.¹ Until recently, there has been little clinical research, also known as clinical trials or studies, about PN symptoms and how well existing drugs work to treat PN.^2,3 However, clinical research is beginning to find new types of drugs that may be more effective for PN.¹

Clinical studies have led to life-changing drugs and better quality of life for many people with skin conditions.⁴ People living with PN can volunteer to join a study and contribute to the science aimed at finding drugs that work and helping doctors understand PN as a disease. Those who participate can help pave the way for potentially more effective treatment options for PN to become available in the future.

See if You May Qualify for a Clinical Trial

If you’re interested in possibly joining a clinical study for PN, it’s important to learn more about how they work and what to expect. Here are some important facts you should know about participating in a clinical study.

New Drugs Are Tested Before Clinical Studies Start

Before a clinical study is designed, a potential new drug is studied in the laboratory. Researchers study cells, computer models, and the results of animal tests of a potential drug to help determine how well it works and how safe it may be.⁵ These studies often take years. If this type of research, called preclinical research, does not find too many or unacceptable safety concerns, research teams will design a clinical study.⁶

Clinical studies are carefully designed around four phases that test the potential new drug to be sure it works in humans and is safe to take, mostly starting in healthy volunteers (phase 1). Phase 2 studies involve people with PN. When a drug moves from phase 1 to phase 2, or from phase 2 to phase 3, the researchers recruit more people and collect more detailed information about the drug.⁷

Rules Are in Place To Protect Your Safety During a Clinical Study

Each country has specific rules for approving clinical study plans. In the United States, a clinical study plan must be reviewed by the U.S. Food and Drug Administration (FDA) to make sure that participants will be protected. This is based on whether the potential benefits outweigh the potential risks.⁶

The FDA also requires clinical study plans to be reviewed by an Institutional Review Board, or IRB, which oversees the well-being and rights of participants in the study. Participants’ safety is carefully monitored and reviewed during each phase. If a drug is found to have too many or unexpected serious side effects, the study will be stopped (either temporarily or permanently).⁸

You’ll Be Fully Informed About Details Before Joining

Clinical studies may last different lengths of time and involve different types and numbers of visits and procedures. Before enrolling in a clinical study, you’ll get detailed information about the clinical study plan, possible risks, and what will happen during the trial. Volunteers are given time to consider research participation and ask questions.⁹

Called “informed consent,” this process allows for open communication between researchers and participants. You’ll be given time to discuss a clinical study with your health care providers and family members.

Cost, Travel, Time, and Other Details

You’ll also have a chance to discuss all parts of the study, including the time required, whether travel costs are paid back, and any out-of-pocket costs.⁹

Placebo in Clinical Studies

If you’re joining a clinical study, it’s important to understand that you might receive a placebo. The placebo will look like the drug being studied, but will not contain active ingredients. A placebo has no medical effect.

Clinical studies often include a randomized, double-blind placebo control group. This means that you will be assigned by chance (like flipping a coin) to either the group that gets the drug being studied or a group that gets the placebo.¹⁰ Depending on the study, if you are in the placebo group, you may sometimes receive a placebo in addition to the standard treatment for your condition.¹⁰ These control groups help show if the drug is measurably better than either the current standard of care or no drug. You can ask if you would remain on your current medication during the study while receiving a drug from the study team.

In double-blind studies, neither the participants nor the researchers know who is taking a placebo. Double-blinding helps to reduce bias and ensure that results are as accurate as possible.⁴

Like All Drugs, Drugs Being Studied Have Potential Risks

Every drug brings a risk of possible side effects, and clinical studies are no exception. Before joining a clinical study, you’ll be advised of possible side effects, or any adverse reactions that have happened so far.¹¹

It’s also important to be aware that if you’re given the drug being studied, it may not be effective.¹¹

You Can Leave a Clinical Trial at Any Time

Joining a clinical study is 100 percent voluntary, and participants have the right to stop at any point.⁹

Read 5 Reasons Why Representation Matters in Clinical Trials for PN.

See if You May Qualify for a Clinical Trial

Talk With Others Who Understand

MyPrurigoTeam is the social network for people with PN and their loved ones. On MyPrurigoTeam, thousands of members come together to ask questions, give advice, and share their stories with others who understand life with PN.

Do you or your loved one have PN and are interested in joining a clinical study? Have you participated in a clinical study before? Share your experience in the comments below, or start a conversation by posting on your Activities page.