2 to 12 Years Olds with Psoriasis Needed for a Research Study

What is the purpose of this study?

We want to learn if the study drug, an ointment applied 2 times a day, is safe for children with psoriasis to use and see how it is handled by the body.

Who can participate?

Children, 2 to 12 years old, with plaque type psoriasis, may be eligible for participation.

What is involved?

If your child qualifies and you decide you want your child to participate in the study, your child will come to Cincinnati Children’s about 4 times over the next 28 days. The visits are as follows:

  • Screening visit to see if your child can be in the study.
  • Baseline visit (day 1 visit) to collect information about your child before he or she can start to use the study drug.
  • There will be 3 phone calls to see how your child is doing and to arrange for more study drug if needed.
  • Day 14 visit to collect information about your child after he or she has been using the study drug.

While in this study, your child will be asked to complete some tests and procedures, including:

  • Medical and medication exam
  • Physical (including height, weight, heart rate, breathing rate, temperature and blood pressure) exam
  • Provide blood and urine samples

The study drug is an ointment that will be spread on your child’s psoriasis 2 times each day (about 12 hours apart) for 13 days.  The study doctor and staff will let you know where to apply it, how to put it on and how much to use. 

A detailed list of procedures will be provided to anyone interested in knowing more about this study.  

What are the benefits?

Being in this study may not help your child right now.  When we finish the study, we hope that we will know more about how the study drug is handled by children’s bodies.  This may help other children with plaque forming psoriasis later on.

Will I get all the facts about the study?

You, as the parent or guardian, will be 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 risks and discomforts of the study?

All possible discomforts or risks will be discussed with you if you are interested in learning more about the study.

Do participants receive pay, compensation or reimbursement?

Participants may receive up to $600 for completing all of the study visits.

Who should I contact for more information?

Laurie Vanderah

513-803-0003

laurie.vanderah@cchmc.org

Cincinnati Children’s Hospital Medical Center

3333 Burnet Avenue

Cincinnati, OH  45229-3039

Principal Investigator

Kara Shah, MD, PhD

Cincinnati Children’s Hospital Medical Center

Division of Dermatology

For more information about this study, visit www.clinicaltrials.gov.