Trial · NCT00967226

Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

NCT00967226, Phase 2, Terminated, Nancy Bauman; results first posted 2016-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas. Trials, record NCT00967226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00967226

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
NCT number: NCT00967226
Status: Terminated
Phases: Phase 2
Enrollment: 19 participants, actual
Lead sponsor: Nancy Bauman
Conditions: Hemangioma of Infancy
Interventions: propranolol, Prednisolone
First posted: 2009-08-27
Last updated: 2016-02-24
Results first posted: 2016-02-24
Limitations and caveats: Not every enrolled participant had an adverse event and some had more than one. The prednioslone participants who had adverse events warranting early withdrawal had severe failure to thrive (\<5th percentile), a serious adverse event.

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Decrease in Size of Hemangioma (Length x Width) in Square mm	4-5 months after initiating therapy	A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available.
Secondary	Tolerability of Medication	enrollment until study close out or withdrawal up to 9 months	All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular.
Secondary	Number of Serious Adverse Events (SAEs)	enrollment until study close out or withdrawal up to 9 months	Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
Secondary	Growth and Development Adverse Events	enrollment to study withdrawal or close out up to 9 months	Number of Growth and Development AEs in each study arm
Secondary	Pulmonary/Respiratory Adverse Events	enrollment through study close out or withdrawal, up to 9 months	Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm
Secondary	Allergy/Immunology Adverse Events	enrollment through study closeout or study withdrawal up to 9 months	Number of allergy/immunology AE per study arm
Secondary	Dermatologic Adverse Events	enrollment to study close out or withdrawal up to 9 months	Number of Dermatologic Adverse Events in each study arm.
Secondary	Endocrinologic Adverse Events	enrollment to close out or study withdrawal up to 9 months	Number of Endocrinologic AEs (of which adrenal crisis does not overlap).
Secondary	Gastrointestinal Adverse Events	enrollment to study withdrawal or study close out up to 9 months	Number of Gastrointestinal AEs in each arm
Secondary	Infectious Adverse Events	enrollment to study withdrawal or close out up to 9 months	Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever)

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Decrease in Size of Hemangioma (Length x Width) in Square mm	4-5 months after initiating therapy	Data available at 4 or 5 months for only 9/11 propranolol participants and for 6/8 prednisolone participants due to missed appointments. Overall, 90% (138/154) study appointments were completed.	mm squared	MEAN
SECONDARY	Tolerability of Medication	enrollment until study close out or withdrawal up to 9 months	All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular. In this table Adverse Events are those exclusive of the Serious Adverse Events which are noted separately.	Events	NUMBER
SECONDARY	Number of Serious Adverse Events (SAEs)	enrollment until study close out or withdrawal up to 9 months		Serious Adverse Events	NUMBER
SECONDARY	Growth and Development Adverse Events	enrollment to study withdrawal or close out up to 9 months		Adverse Events	NUMBER
SECONDARY	Pulmonary/Respiratory Adverse Events	enrollment through study close out or withdrawal, up to 9 months		Adverse Events	NUMBER
SECONDARY	Allergy/Immunology Adverse Events	enrollment through study closeout or study withdrawal up to 9 months		Adverse Events	NUMBER
SECONDARY	Dermatologic Adverse Events	enrollment to study close out or withdrawal up to 9 months		Adverse Events	NUMBER
SECONDARY	Endocrinologic Adverse Events	enrollment to close out or study withdrawal up to 9 months		Adverse Events	NUMBER
SECONDARY	Gastrointestinal Adverse Events	enrollment to study withdrawal or study close out up to 9 months		Adverse Events	NUMBER
SECONDARY	Infectious Adverse Events	enrollment to study withdrawal or close out up to 9 months		Adverse Events	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Decrease in Size of Hemangioma (Length x Width) in Square mm	Propranolol		0.57	95% Confidence Interval 0.34 to 0.80	mm squared
Decrease in Size of Hemangioma (Length x Width) in Square mm	Prednisolone		0.63	95% Confidence Interval 0.14 to 1.11	mm squared
Tolerability of Medication	Overall Number of Adverse Events in Propranolol	Adverse Events	34		Events
Tolerability of Medication	Overall Number of Adverse Events in Prednisolone	Adverse Events	30		Events
Tolerability of Medication	Overall Number of Adverse Events in Propranolol	Serious Adverse Events	1		Events
Tolerability of Medication	Overall Number of Adverse Events in Prednisolone	Serious Adverse Events	11		Events
Number of Serious Adverse Events (SAEs)	Number of Serious Adverse Events in Propranolol		1		Serious Adverse Events
Number of Serious Adverse Events (SAEs)	Number of Serious Adverse Events in Prednisolone		11		Serious Adverse Events
Growth and Development Adverse Events	Growth/Developoment AEs Propranolol		0		Adverse Events
Growth and Development Adverse Events	Growth/Development AEs Prednisolone		1		Adverse Events

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Propranolol	11
Overall Study	STARTED	Prednisolone	8
Overall Study	COMPLETED	Propranolol	9
Overall Study	COMPLETED	Prednisolone	2
Overall Study	NOT COMPLETED	Propranolol	2
Overall Study	NOT COMPLETED	Prednisolone	6

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dermatologic	Skin and subcutaneous tissue disorders	Propranolol	2	11	2
other	Dermatologic	Skin and subcutaneous tissue disorders	Prednisolone	1	8	1
other	Gastrointerstinal	Gastrointestinal disorders	Propranolol	5	11	6
other	Gastrointerstinal	Gastrointestinal disorders	Prednisolone	5	8	6
other	Infection	Infections and infestations	Propranolol	2	11	5
other	Infection	Infections and infestations	Prednisolone	2	8	3
other	Metabolic/Lab	Metabolism and nutrition disorders	Propranolol	1	11	1
other	Metabolic/Lab	Metabolism and nutrition disorders	Prednisolone	0	8	0
other	Pulmonary/respiratory	Respiratory, thoracic and mediastinal disorders	Propranolol	8	11	14
other	Pulmonary/respiratory	Respiratory, thoracic and mediastinal disorders	Prednisolone	3	8	4

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Propranolol
Total, all-cause mortality	Prednisolone
Total, other adverse events	Propranolol	11	11
Total, other adverse events	Prednisolone	8	8
Total, serious adverse events	Propranolol	1	11
Total, serious adverse events	Prednisolone	5	8

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18550886	BACKGROUND	PubMed
19481268	BACKGROUND	PubMed
19631595	BACKGROUND	PubMed
24347141	DERIVED	PubMed
24526257	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Propranolol vs Prednisolone: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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