How Do Clinical Trials Work for Eczema

Clinical trials play a vital role in developing new eczema treatments — and there are more opportunities to participate than ever before. Joining a clinical trial can help advance research, improve care and possibly provide you with access to treatments not yet available to the public. These frequently asked questions can help you better understand clinical trials and decide if participating is right for you.

What is a clinical trial?
A clinical trial is a type of research study designed to evaluate medical interventions with living participants. It helps scientists and doctors answer important questions about new medications, treatments and therapies, especially regarding the safety and effectiveness for conditions such as eczema.

Clinical trials are crucial for developing new treatment options for eczema. Every treatment currently available has had to undergo the clinical trial process first.

Why participate in a clinical trial?
Everyone’s eczema looks and feels different, so clinical trials need diverse participants of all ages, races and eczema types. The greater the variety in who joins, the better we can understand how treatments work across different groups of people.

By taking part in a trial, you may:

• Gain early access to promising new eczema treatments
• Receive extra care, monitoring and support from medical professionals
• Help scientists discover better ways to treat and manage eczema
• Contribute to research that could help others living with eczema in the future
• Be part of something bigger — driving progress in eczema care

Of course, there are also risks to consider. Some people experience side effects from the study treatment. Others may find that the new treatment doesn’t work as well as their current one or, in a randomized study, may receive a placebo. You may also need to attend more appointments than usual, which can take time.

That’s why learning all the details before enrolling is so important — and why the next step, informed consent, is required for every clinical trial.

Watch the video for our answers to your top 5 questions on clinical trials for eczema.

What is informed consent?
Before you join a clinical trial, you’ll go through a process called informed consent. This is not just paperwork — it’s a conversation with the research team to ensure you fully understand the study, including its potential risks and benefits.

Informed consent means the research team will walk you through everything you need to know about the trial, including:

• What treatment is being studied
• What will happen during the trial
• How long it will last
• What the risks and benefits might be
• Your rights as a participant

You’ll have time to review this information, ask as many questions as you’d like and discuss the clinical trial with your family or doctor. Nothing moves forward unless — and until — you feel comfortable.

If you’re enrolling your child, you’ll need to give permission as their parent or guardian. In some cases, children may also be asked to give “assent,” which means they agree to participate in an age-appropriate way.

You can stop participating in the trial at any time. You don’t have to give a reason, and your care won’t be affected. Your safety and comfort always come first.

Who can join a clinical trial?
Each clinical trial has its own guidelines for who can participate, called eligibility criteria. These include:

• Age
• Type and severity of eczema
• Other medical conditions
• Medications you may be taking

Ask your doctor or the trial coordinator if a study is a good fit for you or your child.

Can children join a clinical trial?
Yes. Many clinical trials are open to children with permission from a parent or legal guardian.

Learn how one child, Maya, navigated the clinical trial experience in this video.

Are there different types of clinical trials?
Yes. The two main types are:

• Interventional trials where participants receive a treatment, such as a new drug or therapy. In these trials, researchers actively assign participants to receive a specific treatment — such as a new medication, therapy or medical device — to study its effects. Participants may be randomly assigned different groups to compare the new treatment with a placebo or a standard treatment. The goal is to evaluate safety, effectiveness and outcomes.
• Observational trials where researchers track participants over time without assigning a specific treatment. In observational studies, researchers do not assign any specific treatment. Instead, they monitor participants over time to gather data about their health, behaviors or responses to treatments they’re already receiving as part of regular care. These trials help identify patterns, risk factors and potential connections between lifestyle, environment and health outcomes.

What are the phases of a clinical trial?
Clinical trials typically occur in four phases:

• Phase 1: Tests a new treatment’s safety, determines the optimal dosage and identifies any immediate side effects in a small group of 20–100 healthy volunteers or people with the condition.
• Phase 2: Explores how well the treatment works, continues monitoring safety and helps refine dosing in several hundred participants with the disease or condition.
• Phase 3: Confirms effectiveness, tracks side effects across different populations and compares the new treatment to existing options in 300–3,000 volunteers. Results from this phase are used to apply for FDA approval.
• Phase 4: Takes place after FDA approval to monitor long-term safety, effectiveness and how the treatment performs in real-world, everyday use among thousands of patients.

View our infographic to understand the clinical trial process better

Are clinical trials safe?
Participant safety is a top priority. All clinical trials must be approved by an Institutional Review Board (IRB) and follow strict guidelines. You’ll go through a process called informed consent, where everything about the trial is explained before you agree to participate. You can ask questions, review the trial plan and withdraw at any time for any reason.

What about the cost?
The cost of the treatment being studied and any study-related care is typically covered by the sponsor of the trial. Ask if you’ll be responsible for any co-pays or travel expenses before enrolling.

What happens after the clinical trial?
Some trials may offer continued access to the treatment after the study ends. Be sure to ask the clinical team what happens next.