Clinical trial NCT04020419: Natural Berry Extract Treatment of Hemangiomas
Official title: Natural Berry Extract Treatment of Hemangiomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Hemangioma
Keywords: miR126
Pediaberry
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: National Institutes of Health (NIH)
First posted: 2019-07-16
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot study to determine effect size for possible FDA phase I/II trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Children with hemangiomas ≤ 4 months and 2 weeks of corrected gestational age
* Hemangioma size ≥ 1 cm diameter

Exclusion Criteria:

* Children with hemangiomas that threaten the life of the child or development of vital structures.
* Children who are breast feeding and mother is taking beta blocker medication
* Children with previously treated hemangiomas
* Congenital hemangiomas - cannot distinguish between rapidly involuting and non-involuting congenital hemangiomas
* Hemangiomas located in the perineal/diapering area - product will get contaminated or wiped off with diapering
* Children with food allergies to blueberries or any other kind of berry
* Legal guardian unable to provide informed consent

Primary outcomes:
measure: Decreased Hemangioma Size
timeFrame: 6 month treatment period
Secondary outcomes:
measure: Decreased urinary micro RNA 126 levels
timeFrame: 6 month treatment period
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Indiana University
name: Gayle Gordillo, MD
role: PRINCIPAL_INVESTIGATOR
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