Eczema (Atopic Dermatitis) Study
Eczema (atopic dermatitis) is characterized by itchy, red, crusty patches of skin caused by inflammation. The term ‘eczema’ is broadly applied to a range of persistent skin conditions. These include dryness and recurring skin rashes that are characterized by one or more of the following symptoms: redness, skin swelling, itching, dryness, crusting, flaking, blistering, cracking and oozing. The cause of eczema is unknown but is presumed to be a combination of genetic and environmental factors.
- The purpose of this study is to evaluate the effectiveness of an investigational medication in people with atopic dermatitis. This is a study for an investigational medication which means the FDA has not approved this medication for use in the United States, but the FDA has approved this study to be conducted. This is a randomized, double-blind, placebo-controlled study. Randomized means that you will be randomly assigned to a treatment. It is a lot like flipping a coin. It is done by a computer system that tells the site which medication kits to dispense. It is double blinded which means that neither you nor anyone at the study center will know whether you are getting study medication or placebo. Placebo is an inactive version of the medication. It will look like the study medication, but it will have no medicine inside of it kind of like a “sugar pill”. There is a 50% chance of getting placebo, which means there is a 50% chance of getting study medication.
- This study will last for approximately 12 weeks with a total of 6 office visits. Any subject that completes this study will be given the option to enroll in a long-term study which will last up to a year and no longer include a placebo. This means anyone in the long-term study will not receive placebo but will receive the investigational medication. All subjects will be required to complete a daily diary using an electronic diary provided by the study center. Compliance with the electronic diary is imperative to the success of the study.
- At the screening visit, you will be provided with an informed consent document that will explain all aspects of the study as well as possible side effects, possible risks, study procedures, alternative treatments, etc. This form will be explained to you and you will be able to ask questions. No procedures will be completed prior to the signing of this consent document.
- The screening visit will take approximately 1-2 hours to complete. All subsequent visits will take approximately 1-1 ½ hours to complete.
- Must be between the ages 18 to 70
- Must be in general good health
- Willing to complete up to 8 visits to the study center over a 16-week period
If Qualified and you participate you will receive:
- All study-related medical exams, lab tests, and investigational medication or placebo. Compensation up to (TBD) is available for your time and travel.
Take the next step. Call us at 757-627-6798 and ask for the Eczema enrollment team. Better yet, fill out the brief contact form and we will call you!