The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma

The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.

Study Overview

• Status: Completed
• Conditions: Hemangioma
• Intervention / Treatment: Drug: Prednisolone; Drug: Propranolol

Detailed Description

• Randomized (A group : propranolol, B group : prednisolone)
• A group : 3 days admission and medication for 16 weeks
• B group : medication for 16 weeks without admission
• Hemangioma volume comparison by using MRI
• other measurement and drug adverse reaction monitoring

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seould National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 9 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hemangioma patient ( 0 ~ 9 months old)
• No treatment before
• 10 ~ 20 % volume increase in 2 ~ 4 weeks
• Hemangioma that caused organ function
• Hemangioma that will cause aesthetic problem

Exclusion Criteria:

• Cardiovascular disease (impossible to use propranolol)
• Drug adverse reaction or allergy history (propranolol, steroid)
• Bradycardia, Atrioventricular block, atrial block
• Cardiogenic Shock
• Right heart failure (pulmonary hypertension)
• Congestive heart failure
• Hypotension
• Peripheral nerve disease (moderate)
• Angina
• Hormone deficiency patient
• Pulmonary disease (asthma)
• diabetic ketoacidosis
• laser treatment history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Prednisolone; Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks	Drug: Prednisolone; 2mg/kg/day for 16weeks; Other Names: steroid
EXPERIMENTAL: Propranolol; Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks	Drug: Propranolol; 2mg/kg/day for 16weeks; Other Names: beta-blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO	The primary efficacy variable was the clinical response at 16 weeks, classified as follows: when the volume did not increase or decreased by less than 25% after treatment began, we defined it as stop of progression; when the volume decreased by 25% or more compared with the original size, we defined it as regression. Both stop of progression and regressionwere defined as reaction. If the volume at the primary efficacy evaluation point was greater than the size measured when treatment started,we called it an increase. Increase was defined as a nonreaction.	After 16weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Reduction in Hemangioma Volume From Baseline	Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks))	After 16 weeks
Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks	Number of Participants in which, the Heart rate fell to <70% of acceptable age related minimum post-dose with child awake, anytime during the 16 weeks Count of patients whose Heart rate fall to <70% of acceptable age related minimum post-dose with child awake	up to 16weeks
Number of Participants With Change in Color as Compared to Baseline	Participants were observed for any change in color. The possible change in colors included change to Red/Purple/Blue/Gray/Apricot. Reported are the number of participants who experienced a change in color by the type of color	After 16 weeks
Number of Participants With Size Reduction of Ulceration	size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication)	After 16 weeks
Number of Participants With Reepithelialzation in 16weeks	Number of participants with Reepithelialzation in 16weeks..	After 16 weeks
Number of Participants With Stop of Proliferation	Number of participants whose hemangioma stop proliferating in 16weeks	After 16 weeks
Number of Participants With Regression	Number of participants whose hemangioma showed regression in 16 weeks.	Within 16 weeks
Number of Participants With Drug Compliance Within 16 Weeks	We checked Number of participants with Drug compliance within 16 weeks	After 16 weeks
Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks	Number of Participants in Which, the Systolic blood pressure fall of >25% of baseline postdose with child awake, Anytime During the 16 Weeks..	up to 16weeks
Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks	Number of Participants in Which, Glucose levels fall (to <50mg/dl), Anytime During the 16 Weeks..	up to 16weeks
Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks	Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks..	up to 16weeks
Number of Participants With Growth Retardation Within 16 Weeks	Number of Participants with Growth Retardation within 16 weeks..	up to 16weeks
Number of Participants With Gastroesophageal Reflux Within 16 Weeks	Number of Participants With Gastroesophageal reflux within 16 weeks..	up to 16weeks
Number of Participants With Adverse Drug Reaction	All symptoms associated adverse drug reaction will be checked	up to 16weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Kyung-Duk Park, MD, Ph D, Seoul National University Hospital; Study Director: Tae Hyun Choi, MD, Ph D, Seoul National University Hospital

Publications and helpful links

General Publications

• Kim KH, Choi TH, Choi Y, Park YW, Hong KY, Kim DY, Choe YS, Lee H, Cheon JE, Park JB, Park KD, Kang HJ, Shin HY, Jeong JH. Comparison of Efficacy and Safety Between Propranolol and Steroid for Infantile Hemangioma: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jun 1;153(6):529-536. doi: 10.1001/jamadermatol.2017.0250.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: July 9, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (ESTIMATE): July 26, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Propranolol; steroid; prednisolone; Hemangioma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Hemangioma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Propranolol; Prednisolone
• Other Study ID Numbers: 12172-MM-231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED