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Off Label Use of Propranolol for Infancy Hemangiomas

NCT01211080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2014-11-11

No results posted yet for this study

Summary

Propranolol use for infancy hemangiomas is of world wide interest due to low cost and presumed efficacy. The investigators hypothesized that the drug ist highly active against growing hemangiomas in problematic sites and that there are little side effects.

This observational study was undertaken in an uncontrolled fashion to determine sample size, design and and tools for a later randomized controlled trial on propranolol versus physical therapy (i.e.cryotherapy) which is the most prevalent treatment for the condition. During this initial series side effects and relevant design aspects became evident which warrant expedited reporting.

Conditions

  • Hemangioma

Interventions

DRUG

Propranolol

Propranolol 2mg/kg/day divided to three oral doses with or without concomitant physical therapy (cryotherapy, laser)

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Carsten R Engelmann, MD PhD · Hannover Medical School

  • Benno M Ure, Prof. · Hannover Medical School

Eligibility

Min Age
1 Month
Max Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01211080 on ClinicalTrials.gov