NCT05375955

Introducing a clinical trial for people with eczema (atopic dermatitis) or plaque psoriasis

Atopic dermatitis (AD), the most common form of eczema, causes itchy, dry, cracked, and red skin. It is among the most common dermatological conditions worldwide.

Plaque psoriasis (PsO), the most common form of psoriasis, causes patches of thick, scaly, red skin. It is estimated that about 2% of the world’s population has psoriasis.

The EMPORIA 2 study is evaluating a steroid-free ointment to see if it may safely and effectively reduce symptoms of AD and PsO.

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Who may participate

Joining a clinical trial is an important and personal decision. Thank you for considering the Emporia 2 Study.

The EMPORIA 2 study is enrolling people who:

  • Are 12 years old and older

AND

  • Have had a diagnosis of mild, moderate, or severe PsO for at least 6 months

OR

  • Have had a diagnosis of mild or moderate AD for at least 3 months

There are other requirements for participation in the study.  The study doctor will explain these to you.

Condition

Atopic dermatitis or Psoriasis

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

12 years and older

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

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What to expect

To see if you qualify for the study, you will attend a screening visit where you will be asked health-related questions and may have several study assessments to help determine if the study is a good fit for you.

If you are eligible, you will be randomly assigned to receive a certain dose level of the investigational study medicine or placebo (inactive medicine), by chance rather than by choice.

The study medicine is a steroid free ointment applied to the skin once daily.

Participants will apply their assigned study medicine once daily for 12 weeks. At the end of this period, they will enter the Follow-Up Period of 4-5 weeks. Total study participation will last up to about 21 weeks. 

What happens at each study visit will vary and some study visits may take longer than others.

Length of study treatment

Up to 12 weeks

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

About 10

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

What does participation involve?

What does participation involve?

The investigational study medicine and placebo are administered topically (on your skin) once per day. Participants will need to complete a diary throughout the study to account for the study medicine applied at home.

During this research study, participants will have certain tests, procedures, and assessments. What happens at each study visit will vary and some study visits may take longer than others. Assessments may include a collection of blood and urine samples, physical exams, and questionnaires about participants’ health and quality of life.

Frequently asked questions

Is taking part in this clinical trial voluntary?

Yes, participation in clinical trials is completely voluntary: taking part in a trial is your choice. You are free to stop being in this trial at any time and for any reason and it will not affect your future medical care in any way.

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Why do we need clinical trials?

Clinical trials are important to understand more about potential treatment options for all sorts of conditions. Clinical research studies also help us learn more about the side effects of a potential treatment and to understand whether the possible benefits outweigh the risks.

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Are there any risks?

There are some risks associated with taking any medication, and the investigational study medicine is no different. It is possible your condition or health may improve, worsen, or stay the same. If your health gets worse, the study team and the study doctor will help you decide what to do, which may mean stopping your participation in the study.

Participant safety is the top priority of this clinical trial. Before you participate, you will be provided with an informed consent document that explains the potential risks and benefits in detail. Your health will also be monitored by the study team while in the study.

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Are there any benefits?

Participation may help people in the future by increasing our understanding of the investigational study medicine and atopic dermatitis, but there may be no direct benefit to you.

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What is Informed Consent?

Informed consent is one of the most important tools to help you understand how your rights, safety, and well-being will be addressed throughout the trial.

During informed consent, you will be given all details about the study, including potential benefits and risks of taking part. 

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