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

Primary Purpose

Hemangioma

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prednisolone
Propranolol
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemangioma focused on measuring Hemangioma, Propranolol, prednisolone, steroid

Eligibility Criteria

undefined - 9 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seould National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prednisolone

Propranolol

Arm Description

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Reduction in Hemangioma Volume From Baseline
Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 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
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
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)
Number of Participants With Reepithelialzation in 16weeks
Number of participants with Reepithelialzation in 16weeks..
Number of Participants With Stop of Proliferation
Number of participants whose hemangioma stop proliferating in 16weeks
Number of Participants With Regression
Number of participants whose hemangioma showed regression in 16 weeks.
Number of Participants With Drug Compliance Within 16 Weeks
We checked Number of participants with Drug compliance within 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..
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..
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..
Number of Participants With Growth Retardation Within 16 Weeks
Number of Participants with Growth Retardation within 16 weeks..
Number of Participants With Gastroesophageal Reflux Within 16 Weeks
Number of Participants With Gastroesophageal reflux within 16 weeks..
Number of Participants With Adverse Drug Reaction
All symptoms associated adverse drug reaction will be checked

Full Information

First Posted
July 9, 2013
Last Updated
November 29, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01908972
Brief Title
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
Official Title
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma
Keywords
Hemangioma, Propranolol, prednisolone, steroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone
Arm Type
Active Comparator
Arm Description
Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks
Arm Title
Propranolol
Arm Type
Experimental
Arm Description
Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
steroid
Intervention Description
2mg/kg/day for 16weeks
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
beta-blocker
Intervention Description
2mg/kg/day for 16weeks
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO
Description
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.
Time Frame
After 16weeks
Secondary Outcome Measure Information:
Title
Percent Reduction in Hemangioma Volume From Baseline
Description
Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks))
Time Frame
After 16 weeks
Title
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
Description
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
Time Frame
up to 16weeks
Title
Number of Participants With Change in Color as Compared to Baseline
Description
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
Time Frame
After 16 weeks
Title
Number of Participants With Size Reduction of Ulceration
Description
size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication)
Time Frame
After 16 weeks
Title
Number of Participants With Reepithelialzation in 16weeks
Description
Number of participants with Reepithelialzation in 16weeks..
Time Frame
After 16 weeks
Title
Number of Participants With Stop of Proliferation
Description
Number of participants whose hemangioma stop proliferating in 16weeks
Time Frame
After 16 weeks
Title
Number of Participants With Regression
Description
Number of participants whose hemangioma showed regression in 16 weeks.
Time Frame
Within 16 weeks
Title
Number of Participants With Drug Compliance Within 16 Weeks
Description
We checked Number of participants with Drug compliance within 16 weeks
Time Frame
After 16 weeks
Title
Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks
Description
Number of Participants in Which, the Systolic blood pressure fall of >25% of baseline postdose with child awake, Anytime During the 16 Weeks..
Time Frame
up to 16weeks
Title
Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks
Description
Number of Participants in Which, Glucose levels fall (to <50mg/dl), Anytime During the 16 Weeks..
Time Frame
up to 16weeks
Title
Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks
Description
Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks..
Time Frame
up to 16weeks
Title
Number of Participants With Growth Retardation Within 16 Weeks
Description
Number of Participants with Growth Retardation within 16 weeks..
Time Frame
up to 16weeks
Title
Number of Participants With Gastroesophageal Reflux Within 16 Weeks
Description
Number of Participants With Gastroesophageal reflux within 16 weeks..
Time Frame
up to 16weeks
Title
Number of Participants With Adverse Drug Reaction
Description
All symptoms associated adverse drug reaction will be checked
Time Frame
up to 16weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Duk Park, MD, Ph D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tae Hyun Choi, MD, Ph D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seould National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28423174
Citation
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.
Results Reference
derived

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

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