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

NCT ID: NCT01908972

Last Updated: 2018-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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* 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

Conditions

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Hemangioma

Keywords

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Hemangioma Propranolol prednisolone steroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Prednisolone

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

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

2mg/kg/day for 16weeks

Propranolol

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

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

2mg/kg/day for 16weeks

Interventions

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Prednisolone

2mg/kg/day for 16weeks

Intervention Type DRUG

Propranolol

2mg/kg/day for 16weeks

Intervention Type DRUG

Other Intervention Names

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steroid beta-blocker

Eligibility Criteria

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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
Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-Duk Park, MD, Ph D

Role: STUDY_DIRECTOR

Seoul National University Hospital

Tae Hyun Choi, MD, Ph D

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seould National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28423174 (View on PubMed)

Other Identifiers

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12172-MM-231

Identifier Type: -

Identifier Source: org_study_id