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

Hemangioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908972
• Other study ID #: 12172-MM-231
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma

Intervention

Drug:
• Prednisolone
2mg/kg/day for 16weeks
• Propranolol
2mg/kg/day for 16weeks

Locations

Country	Name	City	State
Korea, Republic of	Seould National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Reepithelialzation in 16weeks	Number of participants with Reepithelialzation in 16weeks..	After 16 weeks
Secondary	Number of Participants With Stop of Proliferation	Number of participants whose hemangioma stop proliferating in 16weeks	After 16 weeks
Secondary	Number of Participants With Regression	Number of participants whose hemangioma showed regression in 16 weeks.	Within 16 weeks
Secondary	Number of Participants With Drug Compliance Within 16 Weeks	We checked Number of participants with Drug compliance within 16 weeks	After 16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Growth Retardation Within 16 Weeks	Number of Participants with Growth Retardation within 16 weeks..	up to 16weeks
Secondary	Number of Participants With Gastroesophageal Reflux Within 16 Weeks	Number of Participants With Gastroesophageal reflux within 16 weeks..	up to 16weeks
Secondary	Number of Participants With Adverse Drug Reaction	All symptoms associated adverse drug reaction will be checked	up to 16weeks