Clinical Trials / Research Studies
Eczema/Atopic Dermatitis Study for Children 2 to 5 Years Old

Eczema/Atopic Dermatitis Study for Children 2 to 5 Years Old

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to evaluate the safety and efficacy of ARQ-151 cream for children with moderate eczema (atopic dermatitis). ARQ-151 is an experimental cream that contains the drug roflumilast and has not been approved by the United States Food and Drug Administration (FDA) for use outside of studies like this one, but it has been applied to subjects with atopic dermatitis or other skin conditions in approximately 20 studies.

Who can participate?

Children 2 to 5 years old who have moderate eczema may be eligible to participate.

Conditions

  • Dermatology

What will happen in the study?

This study includes a screening visit 1-4 weeks prior to 4 visits over 28 days. Here are some of the things that will happen in this study:

Your child will have a/an:

  • Physical exam
  • Blood Test
  • Health screening
  • Assessment of the severity of the eczema
  • Application of the study drug cream

You as a parent will:

  • Follow the instructions from the study doctor
  • Apply study drug to your child’s lesions
  • Answer medical questions
  • Come to all study visits
  • Report any side effects

Parents interested in having their child participate will be emailed/mailed/given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

Your child may receive no direct benefit from participating in this study. However, possible benefits include improvement in eczema with ARQ-151 cream based on results from previous studies. The greatest benefit is that your child may be contributing to research that helps other children and may learn about science. Research studies are essential in finding new and improved treatments and diagnostic tools.

What are the bad things that can happen from this research?

We will discuss possible risks or discomforts with those interested in learning more about the study.

Will you/your child be paid to be in this research study?

Families will receive up to $855, if they meet all requirements and are enrolled until the final, follow-up visit.

Study Doctor

Contact Us.

Kalyani Marathe, MD
Division of Dermatology
Cincinnati Children’s Hospital Medical Center