5 things to know about Eczema and Dermatitis Clinical Trials
Eczema is an extremely unpleasant condition that causes a number of rash-like symptoms in those who experience it. There are several different types of eczema, including multiple types of dermatitis that have a unique set of symptoms and causes.
If you or a loved one has any of these forms of eczema, you may consider volunteering for a clinical trial to help doctors and researchers find answers and help other people suffering from this painful and irritating condition. In this article, we will cover the different types of eczema, how genetics are related to these conditions, currently available treatments, the latest scientific discoveries, and how to find and enroll in clinical trials.
1. What are the Different Types of Eczema?
Eczema refers to a number of related inflammatory skin conditions that manifest as painful, itchy rashes. Eczema has many different causes, depending on the specific type of eczema. While eczema is not infectious, it can damage the skin and create the opportunity for infectious diseases to enter the body.
Atopic dermatitis (a common type of eczema) is typically caused by some sort of allergic reaction. Unfortunately, doctors do not fully understand how atopic dermatitis is triggered and how to effectively control the disease in different people. Since atopic dermatitis is a relatively common condition, there are many dermatology clinical trials trying to determine the causes of and treatments for this condition.
The “atopic” in atopic dermatitis refers to an allergic reaction in a part of the body that is not in contact with the allergen. This means that atopic dermatitis is in most cases caused by a specific allergen (or allergens) from the environment, and atopic dermatitis is often associated with asthma and hay fever (creating the “atopic triad”). However, it is not always easy to determine the allergen that is causing atopic dermatitis. Atopic dermatitis most often manifests in children, though it can also show up much later in life. The disease is sometimes referred to as “atopic eczema.”
By contrast, contact dermatitis is typically caused by a specific allergen or irritant coming into contact with the skin. Contact dermatitis can be caused by a direct allergic reaction (such as an allergic reaction to certain types of grass) or it can be the result of direct skin contact with a chemical irritant (such as household cleaners, gasoline, wood varnish, etc.). Contact dermatitis and atopic dermatitis often have very similar symptoms including red, itchy rashes, dryness, and fluid-filled blisters.
Less common types of eczema include dyshidrotic eczema (usually manifesting on the palms and soles of the feet), hand eczema (more common in people who work with irritating chemicals regularly, such as a hairdresser), neurodermatitis (like atopic dermatitis, though typically triggered by stress), nummular eczema (coin-shaped rashes caused by insect bites and allergens), and stasis dermatitis (a condition that is caused by leaky veins releasing extra fluid into your skin). If you have not had your eczema specifically diagnosed by a general healthcare provider or dermatologist, it is important to do so before you start looking into clinical trials. Most clinical trials are specific to one type of eczema (since each type has very different causes and symptoms).
Most forms of eczema are characterized by inflamed and irritated patches of skin. This inflammation and irritation often leads to itching (pruritus) and scratching, which can lead to an even more severe rash. Often, these rash “flares” can become massively red, swollen, cracked, or even scaly. Depending on where the rashes are located and how often flare-ups occur, the skin can become thickened, leathery, or even discolored from long-term irritation.
2. What Causes Eczema and Dermatitis?
Different forms of eczema and dermatitis are caused by different environmental and genetic factors. Most severe forms of eczema and dermatitis are related to an allergic reaction. Contact dermatitis is often caused by an allergic reaction to something you touched. By contrast, atopic dermatitis is typically caused by an allergic reaction to something you ate or breathed in. These and other forms of eczema can be triggered by specific immune system reactions that are caused in part by your genetics.
Genetics of Eczema and Dermatitis
It is clear that in many forms of eczema and dermatitis, a genetic factor is a play. Dozens of genome-wide association studies (GWAS) have shown a correlation between regions of various chromosomes and eczema or dermatitis. The genes involved likely affect epidermal function, immunity, and the inflammatory response and are influenced by interactions with the environment. Atopic dermatitis has been the most well-researched condition in the eczema family.
The genetics of atopic dermatitis have been studied for several decades, with results indicating that atopic dermatitis has a very strong genetic component. In fact, studies of identical twins have indicated that the heritability of atopic dermatitis is around 70-80%. This is much higher than other skin conditions, such as psoriasis. While atopic dermatitis is highly heritable and tends to run in families, the exact genetic components responsible for causing the disease can vary.
The most well-researched gene that can contribute to atopic dermatitis is the Filaggrin (FLG) gene. This gene codes for a protein that helps maintain the integrity, hydration, and impermeability of the epidermal layer of cells (skin). When this protein is non-functional, allergens are more likely to make their way into deeper layers of the skin, which results in an allergic reaction and the rash flare-ups typical of atopic dermatitis. However, researchers have also identified nearly a dozen other genes that have been correlated with atopic dermatitis. So, the genetics of atopic dermatitis are not fully understood. Some clinical trials and research studies are currently trying to illuminate the role of other genes in eczema and atopic dermatitis.
3. Preventing and Treating Eczema and Dermatitis
Depending on the severity and frequency that you experience flare-ups of your atopic dermatitis, your dermatology healthcare provider may suggest a variety of different treatments. Treatment is also generally different in adult patients vs child patients since pediatric atopic dermatitis typically manifests differently. In general, there are 3 different types of treatments that can be used on atopic dermatitis and eczema in general.
First, most people with any form of eczema are advised to practice advanced skin care techniques. Most often, this includes using a topical moisturizer regularly. This can be more effective if the moisturizer is applied after bathing, as it will help trap water in the top layers of skin. Moisturizing can be effective for some people with this skin condition because it helps replace the moisture loss caused by non-functional proteins in the skin. For many people, moisturizing can greatly improve quality of life and reduce skin infections. Some medications, like crisaborole, are suspended in an ointment cream that may increase their efficacy.
Severe AD may require prescription treatment options. Your doctor may prescribe you a number of different prescription medications to help alleviate your eczema symptoms. One such medication - dupilumab - is a monoclonal antibody treatment used on a number of conditions caused by allergic reactions. Other immunology drugs (like tacrolimus) and biologics have also been used as effective treatments. Topical corticosteroids are sometimes prescribed for the treatment of atopic dermatitis.
There is also phototherapy - a type of UV light treatment - that has been known to have some success in treating eczema in adult subjects. While these treatments can be very effective, they are not always effective for every person. That is why clinical trials and further research are very important. For instance, the Pfizer drug abrocitinib recently completed Phase III clinical trials and is on its way to the market.
4. Latest Discoveries About Eczema and Dermatitis
Since eczema and dermatitis are such common medical conditions, there is a lot of ongoing research on the underlying causes and potential treatments for the symptoms of these conditions. Let’s take a quick look at some of the most recent discoveries and reports.
Some very recent scientific reports implicate the epidermal barrier in eczema and dermatitis. More specifically, scientists are discovering that there are dozens of components of the skin that can contribute to eczema or dermatitis. In fact, many of these components are coded for in a person’s genetics and can lead to an atopic immune reaction, a localized immune reaction, or simply more inflammation from exposure to chemicals. One of these components that has received a lot of attention is filaggrin - an important protein in the skin that helps create an impermeable barrier and can be dysfunctional in severe atopic dermatitis.
While many studies are lucky enough to find treatments that work, some of the most important studies are the ones that find no effect or a decreased outcome for patients. These studies are more important because they can identify dangerous fad treatments before they become popular. For instance, one meta-review identified several bad practices that had been researched in the previous year. The authors found that the timing of allergenic food introduction had no effect on eczema, prebiotics and probiotics had little to no benefit for patients, and in general that few dietary changes (such as fish, omega-3 fatty acids, or polyunsaturated fatty acids) had any effects on the outcomes for patients.
A meta-study reviewing data from 2017 had some interesting insights into eczema and dermatitis. This was the main year that dupilumab products (tested as an open-label product) got thoroughly tested for pharmacokinetics, and appeared to provide a significant benefit for patients and high tolerability. This review also found that bleach baths were no better than water baths for eczema symptoms, examined the weak evidence presented for using topical antibiotics in infected atopic eczema, and showed that fear of skin thinning is a common fear among eczema patients. The authors also reviewed the evidence for dietary exclusion in the management of eczema but found that it was only beneficial when a known food allergy was excluded (rather than searching for an unknown allergen).
Another recent meta-review has looked at the social and psychosocial effects on atopic eczema symptom severy - and vise versa. In other words, the authors of this paper revied the data and found that some forms of stress and psychosocial pressures can exacerbate eczema symptoms, and having eczema symptoms can make mental conditions like stress and anxiety worse. In many people, this can lead to a vicious cycle of eczema flareups and depression or social anxiety. So, those with eczema should be encouraged to seek mental health counseling if they suffer from anxiety or depression - especially if it is related to their eczema.
5. Why Are Clinical Trials Important?
Clinical trials are required by the Food and Drug Administration (FDA) before a new drug or treatment for a disease can be released on the open market. Clinical trials are research studies that use volunteers to test how safe and effective a treatment is before the FDA will “approve” the marketing or sale of a drug to the general public.
Clinical trials have 3 phases. Phase I includes very few volunteers and seeks to ensure that the medication, treatment, or new method of measuring a disease is generally safe to use on humans. Medications, treatments, or diagnostic methods that reach this phase have typically already been tested on animals or cell lines before this point, so it is assumed they will be safe in humans. In Phase II trials, more volunteers are enrolled to test both the safety and efficacy of the procedure with a slightly larger group.
Finally, if the first two phases are passed, enrollment will include thousands of volunteers into a Phase III trial to fully understand how the medication, treatment, or diagnostic technique works and to ensure that side-effects are minimal. If the FDA is satisfied with all three phases, the method may be approved for use by the general public.
Why Do People Join Clinical Studies?
People join clinical trials because clinical trials can only be conducted with volunteers. Therefore, the only way for researchers to actually discover, produce, and market new treatments, medications, and diagnostics is if people with atopic dermatitis volunteer to test them. Sometimes, volunteers are paid a stipend to cover their travel and other trial-related expenses, though volunteers are generally unpaid.
While some participants may get access to the newest medications or treatments, other participants will simply be given a placebo. The placebo is usually a non-active replacement for the treatment that helps researchers fully understand the side effects, outcomes, and physiological effects of their new medication or treatment method. So, there is absolutely no guarantee that you will get medication when you enroll in a placebo-controlled clinical trial. In fact, most studies are double-blind, meaning that even the researchers don’t know who is on medication and who is not until the statistical analysis is conducted at the end of the trial.
Where to Find Clinical Trials
If you are interested in helping find cures, treatments, and diagnostic methods for atopic dermatitis patients, you should consider joining a clinical trial. Since atopic dermatitis is a common condition in populations across the globe, there are many clinical research studies available at any given time.
First, check with your doctor and dermatologist to see if they know of any local clinical trial opportunities that you can join. This can help you find research studies in your area. If there are no studies in your immediate area, you can expand your search on the following sites:
- NIAID Clinical Trials
- ClinicalTrials.gov - Atopic Dermatitis
- National Eczema Association Clinical Trials
- CenterWatch - Eczema Clinical Trials
With each study that you identify as a potential match, search for the “purpose of this study” section. This section usually contains information on what specific forms of eczema or dermatitis are being investigated, along with the interventional treatment being used. Each form of medical research will have a very specific focus and study drug, so be sure to do your research before you start applying.
U.S. National Library of Medicine - Atopic dermatitis
NIH - National Institute of Arthritis and Musculoskeletal and Skin Diseases - Atopic Dermatitis
U.K. National Health Service - Atopic eczema
U.S. National Library of Medicine - Genetics of Atopic dermatitis
Molecular and Clinical Medicine - Genetics in Atopic Dermatitis: Historical Perspective and Future Prospects
Journal of Investigative Dermatology - Eczema Genetics: Current State of Knowledge and Future Goals