NCT04020419

Natural Berry Extract Treatment of Hemangiomas

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Gayle Gordillo · Academic / Other
• Sex: All
• Age: 1 Month – 19 Weeks
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas in infants ≤ 4 months of corrected gestation age over a 6-month treatment period. Subjects will be followed to age 18 months. A total of 44 subjects will be PediaBerry group and 22 subjects in the placebo control group.

Detailed description

PediaBerry™ is a proprietary blend of powdered berry extracts. 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 ). Cream vehicle is mixed with PediaBerry™ or placebo at the time of application.Children will receive once daily topical and oral gavage dosing of PediaBerry or placebo. The first study visit will take place within 2 weeks of subject recruitment. The subject enrollment, consenting and randomization will occur as study visit #0 and will occur at Riley Children's Hospital or Nationwide Children's Hospital. Data collection will be the same at all study visits starting with study visit #1 until the completion of the study. The first dose of PediaBerry™ or placebo will be administered prior to completion of study visit #1, and will also be given at study visits #2-6. Study visits #2-6 will occur monthly study visits until the subject completes 6 months of treatment.Subjects will be weighed and treatment doses adjusted accordingly. Study visits #7-11 to watch for signs of rebound hemangioma proliferation will occur every other month until age 12 months and then at age 15 and 18 months. Urine samples, photos and caliper measurements will occur at each study visit. Some subjects may have less than 11 study visits depending on the age at the time of subject enrollment.

Conditions

• Hemangioma

Interventions

Type	Name	Description
DRUG	PediaBerry	PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-05-24
• Completion: 2023-05-24
• First posted: 2019-07-16
• Last updated: 2023-10-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study