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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone | Active Comparator | Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks |
|
| Propranolol | Experimental | Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | 2mg/kg/day for 16weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Duk Park, MD, Ph D | Seoul National University Hospital | Study Director |
| Tae Hyun Choi, MD, Ph D | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seould National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28423174 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisolone | Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks Prednisolone: 2mg/kg/day for 16weeks |
| FG001 | Propranolol | Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks Propranolol: 2mg/kg/day for 16weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisolone | Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks Prednisolone: 2mg/kg/day for 16weeks |
| BG001 | Propranolol | Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks Propranolol: 2mg/kg/day for 16weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | After 16weeks |
|
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisolone | Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks Prednisolone: 2mg/kg/day for 16weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Blood and lymphatic system disorders | Systematic Assessment | Blood pressure <25% |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Tae Hyun Choi | Seoul National University College of Medicine | 82-10-5595-5829 | psthchoi@snu.ac.kr |
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| ID | Term |
|---|---|
| D006391 | Hemangioma |
| ID | Term |
|---|---|
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D013256 | Steroids |
| D011433 | Propranolol |
| D000319 | Adrenergic beta-Antagonists |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
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| Propranolol | Drug | 2mg/kg/day for 16weeks |
|
|
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 |
| 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 |
| 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 |
| Number of Participants With Reepithelialzation in 16weeks | Number of participants with Reepithelialzation in 16weeks.. | After 16 weeks |
| Number of Participants With Stop of Proliferation | Number of participants whose hemangioma stop proliferating in 16weeks | After 16 weeks |
| Number of Participants With Regression | Number of participants whose hemangioma showed regression in 16 weeks. | Within 16 weeks |
| Number of Participants With Drug Compliance Within 16 Weeks | We checked Number of participants with Drug compliance within 16 weeks | After 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.. | up to 16weeks |
| 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 |
| 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 |
| Number of Participants With Growth Retardation Within 16 Weeks | Number of Participants with Growth Retardation within 16 weeks.. | up to 16weeks |
| Number of Participants With Gastroesophageal Reflux Within 16 Weeks | Number of Participants With Gastroesophageal reflux within 16 weeks.. | up to 16weeks |
| Number of Participants With Adverse Drug Reaction | All symptoms associated adverse drug reaction will be checked | up to 16weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hemangioma volume by MRI | Mean | Standard Deviation | mm^3 |
|
| OG001 |
| Propranolol |
Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks Propranolol: 2mg/kg/day for 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)) | Posted | Mean | Standard Deviation | % from baseline | 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 | Posted | Count of Participants | Participants | No | 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 | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | After 16 weeks |
|
|
|
| Secondary | Number of Participants With Reepithelialzation in 16weeks | Number of participants with Reepithelialzation in 16weeks.. | Posted | Count of Participants | Participants | After 16 weeks |
|
|
|
| Secondary | Number of Participants With Stop of Proliferation | Number of participants whose hemangioma stop proliferating in 16weeks | Posted | Count of Participants | Participants | After 16 weeks |
|
|
|
| Secondary | Number of Participants With Regression | Number of participants whose hemangioma showed regression in 16 weeks. | Posted | Count of Participants | Participants | Within 16 weeks |
|
|
|
| Secondary | Number of Participants With Drug Compliance Within 16 Weeks | We checked Number of participants with Drug compliance within 16 weeks | Posted | Count of Participants | Participants | 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.. | Posted | Count of Participants | Participants | 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.. | Posted | Count of Participants | Participants | 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.. | Posted | Count of Participants | Participants | up to 16weeks |
|
|
|
| Secondary | Number of Participants With Growth Retardation Within 16 Weeks | Number of Participants with Growth Retardation within 16 weeks.. | Posted | Count of Participants | Participants | up to 16weeks |
|
|
|
| Secondary | Number of Participants With Gastroesophageal Reflux Within 16 Weeks | Number of Participants With Gastroesophageal reflux within 16 weeks.. | Posted | Count of Participants | Participants | up to 16weeks |
|
|
|
| Secondary | Number of Participants With Adverse Drug Reaction | All symptoms associated adverse drug reaction will be checked | Posted | Count of Participants | Participants | up to 16weeks |
|
|
|
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Propranolol | Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks Propranolol: 2mg/kg/day for 16weeks | 0 | 17 | 5 | 17 |
|
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| D011083 |
| Polycyclic Compounds |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |