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Natural Berry Extract Treatment of Hemangiomas

NCT04020419 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-10-23

No results posted yet for this study

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.

Conditions

  • Hemangioma

Interventions

DRUG

PediaBerry

PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Gayle Gordillo

    lead OTHER

Principal Investigators

  • Gayle Gordillo, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
19 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-05-24
Completion
2023-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04020419 on ClinicalTrials.gov