Clinical Trials for Eczema

Are you struggling to manage your eczema, even with the treatments prescribed by your primary care doctor or dermatologist? Are you interested in contributing to the advancement of medicine and science? If so, you might be interested in joining an eczema clinical trial.

Before many eczema medications are approved, they must first go through intensive studies known as clinical trials. The purpose of clinical trials is to determine whether an investigational drug is as safe as and more effective than available therapies. In some cases, previously approved treatments for other conditions and diseases are studied for a new application. In others, doctors and researchers monitor the long-term effects and safety of approved medications.

New clinical trials are always launching and recruiting participants. Continue reading to learn more about new eczema treatments and trends being studied and how you can join a clinical trial.

New Eczema Treatments

Eczema is thought to be caused by an overactive immune system responding to substances or triggers.1 Many eczema treatments  currently prescribed help dampen inflammation. Injectable therapies like dupilumab (Dupixent®) target inflammatory messenger proteins known as cytokines, and oral therapies like upadacitinib (Rinvoq®) block signaling proteins that trigger inflammation.

Doctors and researchers continue to search for new ways to block the inflammation that causes red, dry, itchy skin rashes in eczema. New monoclonal antibodies (laboratory-engineered proteins designed specifically to target a part of the immune system), orally available drugs, and topicals are all in clinical trials. Some investigational therapies are also being studied for treating other inflammatory diseases like asthma and chronic cough.2-5

Some investigational treatments work by interfering with different pathways or cytokines that create inflammation, similar to approved treatments. Others belong to an entirely new class of drugs that are revolutionizing how inflammatory conditions and diseases are treated.

Previously Approved Treatments for Eczema

Doctors and researchers also look to previously approved treatments for similar diseases as potential therapies for eczema. Even though one medication may be approved to treat psoriasis, rheumatoid arthritis, or another inflammatory condition, it still needs to be studied in people with eczema to ensure it’s safe and effective for treating eczema.

Investigators may study a previously approved treatment alone or in combination with another approved eczema treatment. Targeting more than one pathway in the immune system may boost the effects of both treatments, improving eczema symptoms better than a single treatment. A previously improved treatment may also be studied in people who haven’t seen symptom improvement with dupilumab or other standard eczema treatments.6,7

Monitoring Approved Treatments for Eczema

After the FDA approves a medication, they continue to monitor it to ensure it’s still safe and effective for the general public. It also gives the opportunity to follow up on people taking the medication for several years after approval to ensure there are no severe or unwanted long-term side effects. Individual studies are known as phase 4 clinical trials or post-marketing surveillance clinical trials.8

During the initial clinical trials for the topical calcineurin inhibitors (TCIs) tacrolimus and pimecrolimus, researchers found that they may increase the risk of lymphoma (a type of blood cancer) and skin cancer. The FDA required a black box warning for these medications after animal studies and a small number of patients reported developing cancer.9

Doctors and researchers continue to monitor people who currently use or have used TCIs in the past to see whether they have developed lymphoma, skin cancer, or thyroid cancer. TCIs are approved for treating both children and adults with moderate-to-severe atopic dermatitis. Clinical trials look to recruit both age groups to determine the long-term effects of using these treatments.10

New Trends in Observational Eczema Clinical Trials

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Clinical trials aren’t just about approving new treatments — they’re also used to collect data in a controlled setting, ensuring it’s as accurate as possible. Normally, interventional clinical trials follow participants who are trying new treatments to gather measurable data through blood tests, imaging tests, and questionnaires about symptoms.

Other studies are more focused on monitoring (observing) participants to learn more about what it’s like to live with eczema and how it affects their quality of life. These studies are known as observational clinical trials, and they provide invaluable information that’s not collected during interventional studies.

Examples of trends that doctors and researchers are investigating in people with eczema include how:11-21

  • New technologies can be used to monitor eczema symptoms, including wearable devices and mobile phone applications
  • Eczema affects overall health, including bone health and density
  • Eczema may affect your microbiome (bacteria found naturally in and on your body)
  • Biomarkers in blood and skin samples can be used to track disease severity
  • Allergies, eczema, and other inflammatory conditions are linked to one another

Observational studies often require less time and travel commitment compared to interventional studies. You may have to provide a blood or skin sample a few times over months to years or get imaging tests done at certain time intervals. If you need to use a medical device, you’ll receive training and will be expected to use it for a specified amount of time. Observational studies still provide doctors and researchers with important information without the added risks of taking an investigational treatment in an interventional trial.22

Joining an Eczema Clinical Trial

If you’re interested in joining an eczema clinical trial near you, it’s important to first understand why you want to participate  and what the benefits and risks may be. Talk with your doctor, family, friends, and the staff of relevant clinical trials to gain insight and perspective. The choice is ultimately up to you as to whether you decide to participate in a clinical trial — always with your best interests in mind.

All clinical trials have a set of criteria for you to participate. Inclusion criteria are requirements you must meet — examples include being within a required age range, taking a specific medication, or having certain eczema symptoms. Exclusion criteria are conditions or situations that prevent you from participating — common examples include being pregnant, having another underlying health condition, or falling outside of the required age range.23

Eligibility criteria are important for keeping you safe as a participant while also ensuring the data aren’t affected by other factors. Many eczema clinical trials investigate new therapies in adults and children since symptoms often begin in childhood. However, the results in one age group may not necessarily translate to another, leading investigators to study both groups separately.