• New eczema treatments must go through clinical trials to make sure the therapies are safe and effective.
• There are many reasons you might want to join a clinical trial — a doctor can help you weigh the risks and benefits.
• Investigators make your safety a top priority if you choose to participate in a clinical trial.

If you’re living with eczema, you might be interested in learning more about how a clinical trial might be right for you. Eczema is a chronic, often lifelong inflammatory skin condition that causes dry, itchy, inflamed skin.¹ The most common form of eczema is atopic dermatitis. While there’s currently no cure for eczema, dermatology providers and researchers continue to learn more about this condition and are finding new ways to treat it.²

New treatments are constantly being studied in clinical trials.³ These studies recruit healthy volunteers or people with eczema or atopic dermatitis to join as participants. Learn more about what clinical trials are, how they work, and whether they may be an option for you.

What Is a Clinical Trial?

A clinical trial is used to determine whether a new drug, medical procedure, or standard of care is safe and effective. Before a new treatment is approved by the U.S. Food and Drug Administration (FDA), it’s studied in a clinical trial.⁴

Investigators — the doctors and researchers running a study — choose a question to specifically ask about a drug.⁵ The point of a clinical trial is to answer this question. For example, investigators may ask whether a new drug is more effective than other drugs. They’ll also use these clinical studies to learn more about a new drug’s adverse events (side effects) and who might benefit the most from treatment.⁵

Together, these pieces are used to create a protocol, or plan, for the study.⁵ The investigators will use the protocol to decide:

• How many participants to include
• Who can participate
• How long the study will last
• What tests will be run to collect data
• How the data will be analyzed

How Do Clinical Trials Work?

Clinical trials are divided into four phases, each testing a different aspect of a new drug. Some phases focus on safety and side effects, while others focus on efficacy, or effectiveness of a treatment.

The four phases of clinical trials include⁶:

• Phase 1 — Small studies, typically with 20 to 80 healthy volunteers, are used to determine dosing and safety.
• Phase 2 — Studies of around 100 to 300 participants investigate safety and efficacy (how effective the new drug is).
• Phase 3 — Large studies with hundreds to thousands of participants are used to confirm an investigational drug’s efficacy.
• Phase 4 — Also known as post-marketing surveillance, phase 4 studies monitor the safety and efficacy of treatments after they’re approved by the FDA.⁷

During each phase, the investigators choose specific measurements to take during the trial and set goals, or endpoints.⁸ These endpoints are used to answer their study questions. An example of an endpoint would be that the new drug improves a participant’s skin symptoms by 75 percent.⁸

What Is a Placebo-Controlled Study?

When you’re reading about clinical trials, you’ll probably come across many terms you aren’t familiar with. One of these words may be “placebo” — this refers to an inactive treatment.⁹ Placebo is a substance that looks similar to the drug but does not contain any drug or active ingredients. It is used as a control or comparison to a new drug. It helps set a baseline for investigators to learn how effective or ineffective a new drug is.

The “gold standard” for clinical trials is a randomized, double-blind, placebo-controlled study. In this type of study, investigators randomly assign participants to receive either placebo or the investigational drug.¹⁰

“Double-blind” means that both the participants and the researchers are unaware of who got placebo or the new drug. A double-blind study helps investigators figure out how much of a person’s response might be due to psychological effects.¹¹ This is known as the placebo effect.¹⁰ It’s important to make sure studies are as accurate and unbiased as possible to measure how well an investigational drug actually works.

Joining a Clinical Trial

When deciding whether to participate in a clinical trial, it’s important to first weigh the benefits and risks to you individually. Be sure to talk with your doctor, the clinical trial staff, and your family. It’s also important to note that as a clinical trial participant, you’re a volunteer and you have the right to leave a study at any time.⁶

There are always side effects and risks when taking medication.⁹ This is especially true with investigational drugs being studied in clinical trials. Researchers are still learning about how safe and effective a drug is. When you join a study, you’ll be informed of the potential side effects or adverse reactions that are known.

Even if you do receive the investigational drug, there’s no guarantee it’ll be effective.¹² It’s possible that development of investigational drugs reaches the stages of phase 2 or even phase 3 before it’s found that the drug doesn’t work as well as researchers expected.

After you enroll in a clinical trial, there’s a chance you’ll be randomly assigned to receive placebo instead of the investigational drug.¹² Your health will be closely monitored throughout a clinical study, and it’s possible that your condition could improve, stay the same, or worsen, irrespective of which treatment you are receiving in the study.

Safety in Clinical Trials

Investigators prioritize your safety as a clinical trial participant. The FDA enforces a strict set of rules and guidelines for clinical studies.¹³

Clinical trials also go through review by an Institutional Review Board (IRB), or a committee made up of health care professionals, researchers, and community members.⁶ The IRB monitors the clinical trial and protects the rights and safety of participants. If a new drug causes harm to participants or causes severe adverse events, the IRB will suspend or terminate a study.⁶

Nearly anyone can choose to participate in a clinical trial — including children and teenagers (with their parent’s or guardian’s permission), as well as adults.¹⁴ Be sure to check the clinical trial’s criteria, as not everyone qualifies for every study.

When you’ve found an eczema research study you qualify for, a staff member from the clinical study center will go over the informed consent document with you.⁶ This process ensures that you have all the important information you need to join a study. It’s also your time to ask questions and communicate with the trial staff.

Information you’ll receive in the informed consent document includes⁶:

• The purpose of the study
• The new drug being investigated
• How long the study will last
• The risks and benefits to you
• Any tests or procedures you’ll need during the study

Why Join a Clinical Trial?

Everyone has their own reason for participating in a clinical trial. Some people want to take a more active role in their health.¹⁴ Others want to support advancing science and help with bringing new drugs to market that can help people with eczema or atopic dermatitis in the future.

If you’re interested in participating in an eczema clinical trial, talk to your health care provider or dermatologist. They can recommend some studies near you that you may qualify for and will keep you up to date on the latest news about new treatments.