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Propranolol in Capillary Hemangiomas

NCT00744185 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-07-19

No results posted yet for this study

Summary

The investigators observed that Propranolol, a beta-blocker commonly used in children was efficient to control the growth of alarming hemangiomas of the face.

The primary objective of this study is to determine the efficiency of 1 month-early treatment of propranolol in infants aged less than 4 months affected by an hemangioma without any consequences on vital or functional structure and not justifying corticosteroids.

The secondary objectives are:

* the kinetic of the hemangioma evolution in infants treated by propranolol
* Observance
* Safety

Conditions

  • Hemangioma, Capillary

Interventions

DRUG

propranolol treatment

30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days

DRUG

placebo treatment

30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Nicholas Moore, Professor · University Hospital Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • France

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 NCT00744185 on ClinicalTrials.gov