Clinical trial NCT01908972: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemangioma
Keywords: Hemangioma
Propranolol
prednisolone
steroid
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 34
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO
timeFrame: After 16weeks
Secondary outcomes:
measure: Percent Reduction in Hemangioma Volume From Baseline
timeFrame: After 16 weeks
measure: 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
timeFrame: up to 16weeks
measure: Number of Participants With Change in Color as Compared to Baseline
timeFrame: After 16 weeks
measure: Number of Participants With Size Reduction of Ulceration
timeFrame: After 16 weeks
measure: Number of Participants With Reepithelialzation in 16weeks
timeFrame: After 16 weeks
measure: Number of Participants With Stop of Proliferation
timeFrame: After 16 weeks
measure: Number of Participants With Regression
timeFrame: Within 16 weeks
measure: Number of Participants With Drug Compliance Within 16 Weeks
timeFrame: After 16 weeks
measure: Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks
timeFrame: up to 16weeks
measure: Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks
timeFrame: up to 16weeks
measure: Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks
timeFrame: up to 16weeks
measure: Number of Participants With Growth Retardation Within 16 Weeks
timeFrame: up to 16weeks
measure: Number of Participants With Gastroesophageal Reflux Within 16 Weeks
timeFrame: up to 16weeks
measure: Number of Participants With Adverse Drug Reaction
timeFrame: up to 16weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seould National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Duk Park, MD, Ph D
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Tae Hyun Choi, MD, Ph D
role: STUDY_DIRECTOR
References:
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.