Where to Find Atopic Dermatitis Clinical Trials
Atopic dermatitis (a 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 causes and treatments of this condition.
If you have atopic dermatitis (AD), you may consider volunteering for a clinical trial to help doctors and researchers find answers and help other people suffering from atopic dermatitis and other forms of eczema. In this article, we will cover what atopic dermatitis and eczema are, how genetics are related to these conditions, currently available treatments, and how to find and enroll in clinical trials.
What are Atopic Dermatitis and 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. The “atopic” in atopic dermatitis refers to an allergic reaction. This means that atopic dermatitis is in most cases caused by a specific allergen (or allergens) from the environment. However, it is not always easy to determine the allergen that is causing atopic dermatitis. The disease is sometimes referred to as “atopic eczema.”
Both general eczema and atopic dermatitis 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. Atopic dermatitis most often manifests in children, though it can also show up much later in life.
Genetics of Atopic Dermatitis
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.
Are there Treatments for Mild or Severe Atopic 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.
First, most people with any form of eczema are advised to practice advanced skincare 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.
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.
What Are Clinical Trials?
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 in 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 a 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
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