Atopic dermatitis, commonly known as eczema, is a chronic skin condition characterized by inflammation, redness, and itching. This condition affects millions of individuals in the United States, often disrupting their daily lives. Clinical trials play a crucial role in advancing our understanding of atopic dermatitis and discovering innovative treatments to improve patient outcomes. Below, we provide an in-depth guide to clinical trials for atopic dermatitis in the United States, covering their significance, benefits, and how to participate.
What Are Clinical Trials for Atopic Dermatitis?
Clinical trials are research studies conducted to evaluate the safety, effectiveness, and potential side effects of new treatments, therapies, or interventions. For atopic dermatitis, these trials may focus on:
- Developing new medications: Testing innovative treatments to manage or cure symptoms.
- Understanding disease mechanisms: Studying the underlying causes of atopic dermatitis.
- Exploring alternative therapies: Examining the efficacy of holistic or non-drug approaches, such as diet or lifestyle changes.
Who Can Participate in Clinical Trials for Atopic Dermatitis?
Eligibility for participation depends on the specific trial and its criteria.
- Diagnosis: Participants must have a confirmed diagnosis of atopic dermatitis.
- Age: Trials may target children, adolescents, or adults depending on the study.
- Severity: Some trials focus on mild cases, while others require moderate-to-severe symptoms.
- Previous Treatments: Trials may look for individuals who have not responded to standard treatments.
- General Health: Participants should meet specific health criteria to ensure safety.
Benefits of Joining a Clinical Trial
Participating in a clinical trial offers several benefits:
- Access to New Treatments: Participants often receive cutting-edge therapies before they become widely available.
- Personalized Care: Trials involve close monitoring and detailed evaluations by healthcare professionals.
- Advancing Science: Contributing to research helps improve treatments for future generations.
- Compensation: Many trials provide financial incentives for time, travel, and participation.
Ongoing Clinical Trials for Atopic Dermatitis in the USA
Clinical Trials.Gov allows you to search for clinical trials for Atopic Dermatitis
A Study Evaluating APG777 in Atopic Dermatitis
This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A will evaluate the safety and efficacy of one induction dose regimen of APG777 compared to placebo. In addition, two maintenance regimens will be evaluated in Part A. Part B will evaluate the benefit-risk of 3 dose regimens of APG777 compared to placebo. One maintenance regimen will be evaluated in Part B. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.
Topical Treatment for Atopic Dermatitis
Medication adherence is a poorly studied phenomenon that challenges both patients and physicians. 50% of individuals with chronic disease are not adherent to their medication regimen. Within the United States, non-adherence to medical treatment leads to approximately $100 billion in hospital admission costs. While the issue of adherence is not limited to any particular field of medicine, non-adherence occurs in approximately one-third to one-half of dermatological patients. Non-adherence is of importance as it is a significant cause of treatment failure, resulting in worse quality of life, worse health outcomes, and increased insurance costs.
Topical ENS-002 for Atopic Dermatitis in Adults
The goal of this study is to determine the safety and effects of ENS-002, a live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria in participants with atopic dermatitis.
Study of ATI-2138 in Adult Participants with Moderate to Severe Atopic Dermatitis
This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.Detailed DescriptionThis open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ATI-2138 administered over 12 weeks.Official TitleA Phase 2a Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of ATI-2138 Administered Over 12 Weeks in Participants with Moderate to Severe Atopic Dermatitis
Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.
The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).Official TitleLong-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis.
What to Expect During a Clinical Trial
1. Screening Process
Researchers will conduct an initial assessment to determine if you meet the eligibility criteria. This typically involves physical exams, lab tests, and medical history reviews.
2. Informed Consent
Participants receive detailed information about the study, including its purpose, duration, potential risks, and benefits. You will need to sign a consent form before joining.
3. Study Phases
- Phase 1: Testing the safety of a new treatment on a small group.
- Phase 2: Evaluating the effectiveness of the treatment on a larger group.
- Phase 3: Confirming efficacy and monitoring side effects on a broader scale.
- Phase 4: Post-approval studies to gather additional data.
4. Participation
You will be assigned to a specific treatment group, which may include receiving the experimental treatment, a placebo, or standard care. Regular visits to the study site for check-ups and monitoring are required.
Safety and Ethical Considerations
Clinical trials in the U.S. are regulated by the Food and Drug Administration (FDA) and Institutional Review Boards (IRBs) to ensure participant safety. Before joining, it’s essential to understand the potential risks and benefits, which will be clearly explained during the informed consent process.
Conclusion
Clinical trials for atopic dermatitis are essential for developing innovative treatments and improving patient care. Whether you’re seeking new therapy options or want to contribute to advancing medical research, participating in a clinical trial can be a rewarding experience. Explore the opportunities near you and consult with your dermatologist to determine if joining a trial is the right choice for you.
