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Trial · NCT01074437

Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

NCT01074437, Phase 2, Terminated, Seattle Children's Hospital; results first posted 2013-09-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH). Trials, record NCT01074437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01074437

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Trial

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

Title
Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
NCT number
NCT01074437
Status
Terminated
Phases
Phase 2
Enrollment
9 participants, actual
Lead sponsor
Seattle Children's Hospital
Conditions
Hemangioma
Interventions
Prednisolone (Corticosteroid), Propranolol, Placebo
First posted
2010-02-24
Last updated
2018-10-04
Results first posted
2013-09-26
Limitations and caveats
Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.

Source ClinicalTrials.gov

Registered outcomes5

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

ListOutcomeTime frameDescription
PrimaryCompare Changes in IH Size and Vascularity for the Two Treatment Groups1, 2, and 6 months after treatment initiationThis outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
PrimaryLesion Regression12 monthsmeasure of change in lesion area or volume
SecondaryDetermine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.1, 2, and 6 months after treatment initiationThis outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
SecondaryAssess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.1, 2 and 6 months after treatment initiationThis outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
Secondary
Demonstrate How Duplex Scanning to Assess Blood Vessel Density and Qualitative Color Ratings of Cutaneous Lesions From Photographs Can be Used to Measure and Quantify Changes in IH Size and Vascularity in a Clinically Relevant Manner.
1, 2 and 6 months after treatment initiationThis outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.

Outcomes5

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYCompare Changes in IH Size and Vascularity for the Two Treatment Groups1, 2, and 6 months after treatment initiationThis outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
PRIMARYLesion Regression12 monthsInsufficient enrollment for data analysis to be meaningful.
SECONDARYDetermine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.1, 2, and 6 months after treatment initiationThis outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
SECONDARYAssess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.1, 2 and 6 months after treatment initiationThis outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
SECONDARY
Demonstrate How Duplex Scanning to Assess Blood Vessel Density and Qualitative Color Ratings of Cutaneous Lesions From Photographs Can be Used to Measure and Quantify Changes in IH Size and Vascularity in a Clinically Relevant Manner.
1, 2 and 6 months after treatment initiationThis outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.

Results by group0

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

None in this release.

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDGroup A: Corticosteroid With Placebo4
Overall StudySTARTEDGroup B: Corticosteroid With Propranolol5
Overall StudyCOMPLETEDGroup A: Corticosteroid With Placebo4
Overall StudyCOMPLETEDGroup B: Corticosteroid With Propranolol5
Overall StudyNOT COMPLETEDGroup A: Corticosteroid With Placebo0
Overall StudyNOT COMPLETEDGroup B: Corticosteroid With Propranolol0

Adverse events0

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

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityGroup A: Corticosteroid With Placebo
Total, all-cause mortalityGroup B: Corticosteroid With Propranolol
Total, other adverse eventsGroup A: Corticosteroid With Placebo04
Total, other adverse eventsGroup B: Corticosteroid With Propranolol05
Total, serious adverse eventsGroup A: Corticosteroid With Placebo04
Total, serious adverse eventsGroup B: Corticosteroid With Propranolol05

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
20674045BACKGROUNDPubMed
21493392BACKGROUNDPubMed

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
Group A: Corticosteroid With Placebo vs Group B: Corticosteroid With Propranolol: serious adverse events

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.

GET https://conductscience.org/api/trials/v1/NCT01074437

GET https://conductscience.org/api/trials/v1/NCT01074437/registered