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

NCT01908972 | Completed Phase 4 Results DMC

• 1 other identifier: 12172-MM-231
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemangioma

Keywords

Hemangioma; Propranolol; prednisolone; steroid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Percent Reduction in Hemangioma Volume From Baseline

  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

  up to 16weeks

• Number of Participants With Change in Color as Compared to Baseline

  After 16 weeks

• Number of Participants With Size Reduction of Ulceration

  After 16 weeks

• Number of Participants With Reepithelialzation in 16weeks

  After 16 weeks

Study Arms (2)

Prednisolone

ACTIVE COMPARATOR

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

Drug: Prednisolone

Propranolol

EXPERIMENTAL

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

Drug: Propranolol

Interventions

Prednisolone DRUG

2mg/kg/day for 16weeks

Also known as: steroid

Prednisolone

Propranolol DRUG

2mg/kg/day for 16weeks

Also known as: beta-blocker

Propranolol

Eligibility Criteria

• Age: Up to 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seould National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28423174 DERIVED

MeSH Terms

Conditions

Hemangioma

Interventions

Prednisolone; Steroids; Propranolol; Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Limitations and Caveats

Although the sample size in the present study was predetermined to show noninferiority, it is difficult to provide strong evidence of safety outcomes. The present study was not a double-blind trial.

Results Point of Contact

• Title: Prof. Tae Hyun Choi
• Organization: Seoul National University College of Medicine

psthchoi@snu.ac.kr

82-10-5595-5829

Study Officials

• Kyung-Duk Park, MD, Ph D

  Seoul National University Hospital

  STUDY DIRECTOR

• Tae Hyun Choi, MD, Ph D

  Seoul National University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 26, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 19, 2018
• Results First Posted: October 26, 2018

Record last verified: 2016-02

Locations

KR (1)