Clinical Trials / Research Studies
Keloid and Hypertrophic (Excessive and/or Raised) Scar Study For Teens and Adults 17 to 28 Years Old

Keloid and Hypertrophic (Excessive and/or Raised) Scar Study For Teens and Adults 17 to 28 Years Old

Why are we doing this research?

Cincinnati Children’s and UC Health are conducting a research study, sometimes known as a clinical trial or clinical study, to see if the study drug itraconazole is safe and effective on the appearance and length of hypertrophic (raised) scars and keloids (excessive scars).

Who can participate?

Teens and adults 17 to 28 years old with hypertrophic scars or keloids who are or will be scheduled for their surgical removal may be considered eligible to participate.

Conditions

  • Dermatology
  • Adult Studies

What will happen in the study?

If eligible and once enrolled in this study, you, as the adult participant, or your teen will come to Cincinnati Children’s or University of Cincinnati Health for 13 study visits over a period of about a year.

During the study visits the study doctor or study staff will:

  • Explain the study and what you would have to do
  • Ask you and your parent (if 17) questions about your health, allergies, medicines and medical care received or are currently receiving
  • Collect your or your teen’s vital signs (temperature, blood pressure, and heart rate)
  • Collect blood and urine samples for lab tests
  • Perform a physical exam based on any symptoms
  • Perform an electrocardiogram (ECG) to see how your or your teen’s heart is working
  • Perform assessments using scales
  • Measure your or your teen’s scar/keloids
  • Provide you or your teen with the study drug or placebo
  • Provide you with a link to complete a daily study diary and review how to complete the study diary with you
  • Check to make sure you or your teen are taking the study drug as per instructions
  • Take pictures of your or your teen’s scar/keloids
  • Perform the excision surgery on your or your teen’s scar/keloids to remove them
  • For females, complete blood or urine pregnancy tests while in this study. The test results must be negative to participate in the study.

As part of this study, participants will receive either itraconazole placebo (a look-alike with no active drug) and use before or after surgery. You or your teen will be randomly assigned to one of 2 groups that will receive either itraconazole or placebo. This assignment is random and done by a computer. One out of every 2 participants will receive placebo (like flipping a coin).

Two of the visits may be completed remotely. You will be given a consent form that thoroughly explains all of the details of the study. 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?

You, as an adult participant, or your teen may not have a medical benefit from being in this research study. However, data and information collected from this study may help others with hypertrophic scars or keloids in the future.

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

Possible risks and discomforts will be discussed with those interested in learning more about the study.

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

Participants will receive up to $325 for time and effort to complete 13 study visits.

Contact

Contact Us.
Study Coordinator
513-636-1212
keloidstudy@cchmc.org

Study Doctor

Contact Us.
Brian Pan, MD
Division of Plastic Surgery
Cincinnati Children’s

David Smith, MD
Pediatric Otolaryngology
Cincinnati Children’s

Ryan Collar, MD
Otolaryngology-Head and Neck Surgery
University of Cincinnati Health