HemangiomaPhase 4NCT01908972
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
A Phase 4 study testing Prednisolone and Propranolol in people with Hemangioma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma. Read more about this study
- Who is it for?
- Ages Up to 9 months
- Conditions the study is for
- Hemangioma
- What is being tested?
- Prednisolone and Propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to May 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Hypotension
- Peripheral nerve disease (moderate)
- Angina
- Hormone deficiency patient
- Pulmonary disease (asthma)
- diabetic ketoacidosis
- laser treatment history
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.
Read the 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
- Conditions
- Hemangioma
- Being tested
- Prednisolone, Propranolol
- Keywords
- Hemangioma, Propranolol, prednisolone, steroid
- Medical subject headings
- Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called steroid
2mg/kg/day for 16weeks
PropranololDrug
Also called beta-blocker
2mg/kg/day for 16weeks
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Active comparator | Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks Receives: Drug: Prednisolone |
| Propranolol | Experimental | Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 16weeks
Secondary outcomes (14)
Percent Reduction in Hemangioma Volume From Baseline
Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks))
Measured: 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
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
Measured: 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
Measured: 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)
Measured: After 16 weeks
Number of Participants With Reepithelialzation in 16weeks
Number of participants with Reepithelialzation in 16weeks..
Measured: After 16 weeks
Number of Participants With Stop of Proliferation
Number of participants whose hemangioma stop proliferating in 16weeks
Measured: After 16 weeks
Number of Participants With Regression
Number of participants whose hemangioma showed regression in 16 weeks.
Measured: Within 16 weeks
Number of Participants With Drug Compliance Within 16 Weeks
We checked Number of participants with Drug compliance within 16 weeks
Measured: 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..
Measured: 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..
Measured: 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..
Measured: up to 16weeks
Number of Participants With Growth Retardation Within 16 Weeks
Number of Participants with Growth Retardation within 16 weeks..
Measured: up to 16weeks
Number of Participants With Gastroesophageal Reflux Within 16 Weeks
Number of Participants With Gastroesophageal reflux within 16 weeks..
Measured: up to 16weeks
Number of Participants With Adverse Drug Reaction
All symptoms associated adverse drug reaction will be checked
Measured: up to 16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyung-Duk Park, MD, Ph D, Study director, Seoul National University HospitalTae Hyun Choi, MD, Ph D, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908972
- Sponsor's protocol ID
- 12172-MM-231
- Status last verified
- Feb 2016
- First submitted
- 9 Jul 2013
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28423174
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
- ClinicalTrials.gov ID
- NCT01908972
- Acronym / sponsor ID
- 12172-MM-231
- Conditions
- Hemangioma
- Keywords
- Hemangioma, Propranolol, prednisolone, steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Posted 26 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Active comparator | Drug: PrednisolonePatients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks |
| Propranolol | Experimental | Drug: PropranololPatients who will receive propranolol medication 2 mg/kg/day for 16 weeks |
Who may qualify
- Ages
- Up to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneAlso: steroid2mg/kg/day for 16weeks | Drug | Prednisolone |
| PropranololAlso: beta-blocker2mg/kg/day for 16weeks | Drug | Propranolol |
Primary outcome
Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO
Time frame: After 16weeks
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.
14 secondary outcomes
Percent Reduction in Hemangioma Volume From Baseline
Time frame: 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
Time frame: up to 16weeks
Number of Participants With Change in Color as Compared to Baseline
Time frame: After 16 weeks
Number of Participants With Size Reduction of Ulceration
Time frame: After 16 weeks
Number of Participants With Reepithelialzation in 16weeks
Time frame: After 16 weeks
Number of Participants With Stop of Proliferation
Time frame: After 16 weeks
Number of Participants With Regression
Time frame: Within 16 weeks
Number of Participants With Drug Compliance Within 16 Weeks
Time frame: 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
Time frame: up to 16weeks
Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks
Time frame: up to 16weeks
Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks
Time frame: up to 16weeks
Number of Participants With Growth Retardation Within 16 Weeks
Time frame: up to 16weeks
Number of Participants With Gastroesophageal Reflux Within 16 Weeks
Time frame: up to 16weeks
Number of Participants With Adverse Drug Reaction
Time frame: up to 16weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28423174Kim 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hemangioma
Not yet recruitingObservational study
Observation Study on the Efficacy and Safety of Hepatic Artery Embolization Combined With Radiofrequency Ablation for Hepatic Hemangioma: The Impact of Different Treatment Intervals
Hepatic Hemangioma
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
Not yet recruitingPhase 1
Study to Establish Safety, Tolerability and Pharmacokinetics of NRL-1049 in Healthy Adult Participants Following Multiple-Dose Administration
Cerebral Cavernous Malformation
Not yet recruitingPhase 2
Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains
Port Wine Stains
RecruitingPhase 3
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Duk Park, MD, Ph D study director
Seoul National University Hospital
Tae Hyun Choi, MD, Ph D study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone and Propranolol in people with Hemangioma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO (time frame: After 16weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.