Natural Berry Extract Treatment of Hemangiomas

(Pediaberry Trial)

Recruiting at 1 trial location

Overseen By Bryce Hockman, CCRP

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Indiana University

Must not be taking: Beta blockers

Disqualifiers: Life-threatening hemangiomas, Congenital hemangiomas, Berry allergies, others

Compensation: Varies

Number of Visits: 12

Duration: 6 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests PediaBerry™, a powdered mix of berry extracts, on infants with hemangiomas. The treatment is applied on the skin and given orally to help reduce these benign growths.

Who Is on the Research Team?

Gayle Gordillo, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

Inclusion Criteria

Hemangioma size ≥ 1 cm diameter

Infants younger than 4 months and 2 weeks, who have hemangiomas (abnormal growth of blood vessels) and were born prematurely.

Exclusion Criteria

Legal guardian unable to provide informed consent

You have hemangiomas (abnormal clusters of blood vessels) located in the diaper area, and the study product may get wiped off or contaminated during diaper changes.

Children who have had hemangiomas in the past and were treated for them.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive once daily topical and oral gavage dosing of PediaBerry or placebo for hemangioma treatment

6 months

6 visits (monthly, in-person)

Follow-up

Participants are monitored for signs of rebound hemangioma proliferation and other safety measures

12 months

5 visits (every other month until 12 months, then at 15 and 18 months)

What Are the Treatments Tested in This Trial?

Interventions

• PediaBerry

How Is the Trial Designed?

Group I: Pediaberry group Experimental Treatment 1 Intervention

PediaBerry™ is a proprietary blend powdered berry extracts

Group II: Placebo Placebo Group 1 Intervention

Placebo: powdered sugar plus McCormick Color from Nature Food Colors Berry and Sky Blue powdered food color (https://www.mccormick.com/spices-and-flavors/extracts-and-food-colors/food-colors/color-from-nature-assorted-food-color ).

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Gayle Gordillo

Lead Sponsor

Trials

6

Recruited

150+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+