ClinicalTrials.gov
ClinicalTrials.gov Menu

Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00967226
Recruitment Status : Terminated (Serious adverse events with prednisolone, primarily temporary growth retardation, <5th percentile.)
First Posted : August 27, 2009
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Nancy Bauman, Children's Research Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hemangioma of Infancy
Interventions: Drug: propranolol
Drug: Prednisolone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Propranolol

Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas

propranolol: propranolol 0.67 mg/kg p.o. TID 4-6 months

Prednisolone

Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.

Prednisolone: 1.0 mg/kg p.o. BID 4-6 months


Participant Flow:   Overall Study
    Propranolol   Prednisolone
STARTED   11   8 
COMPLETED   9   2 
NOT COMPLETED   2   6 
Adverse Event                0                5 
Protocol Violation                2                0 
Physician Decision                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Infants 2 weeks - 6 months of age with symptomatic, proliferating, infantile hemangiomas

Reporting Groups
  Description
Propranolol

Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas

Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)

Prednisolone

Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.

Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)

Total Total of all reporting groups

Baseline Measures
   Propranolol   Prednisolone   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   8   19 
Age 
[Units: Months]
Mean (Full Range)
 4.0 
 (2.8 to 5.2) 
 2.5 
 (1.7 to 3.4) 
 3.4 
 (1.7 to 5.2) 
Gender 
[Units: Participants]
     
Female   8   6   14 
Male   3   2   5 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   2   3 
White   9   6   15 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   5   5   10 
Not Hispanic or Latino   6   3   9 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   11   8   19 
Total surface area (length x width) 
[Units: Mm squared]
Mean (Full Range)
 5.0 
 (1.9 to 25.6) 
 3.1 
 (0.8 to 10.5) 
 4.2 
 (0.8 to 25.6) 
Adjusted total surface area (length x width x proportion of skin involved 
[Units: Mm squared]
Mean (Full Range)
 5.0 
 (1.5 to 24.3) 
 2.5 
 (0.2 to 9.4) 
 4.0 
 (0.2 to 24.3) 
Ulceration [1] 
[Units: Participants]
 2   1   3 
[1] (not present in all participants)
Morphology [1] 
[Units: Participants]
     
Local   6   8   14 
Segmental   3   0   3 
Intermediate   2   0   2 
[1] Local, Segmental, Intermediate
Depth 
[Units: Participants]
     
superficial   3   2   5 
deep   2   2   4 
mixed   6   4   10 


  Outcome Measures

1.  Primary:   Decrease in Size of Hemangioma (Length x Width) in Square mm   [ Time Frame: 4-5 months after initiating therapy ]

2.  Secondary:   Tolerability of Medication   [ Time Frame: enrollment until study close out or withdrawal up to 9 months ]

3.  Secondary:   Number of Serious Adverse Events (SAEs)   [ Time Frame: enrollment until study close out or withdrawal up to 9 months ]

4.  Secondary:   Growth and Development Adverse Events   [ Time Frame: enrollment to study withdrawal or close out up to 9 months ]

5.  Secondary:   Pulmonary/Respiratory Adverse Events   [ Time Frame: enrollment through study close out or withdrawal, up to 9 months ]

6.  Secondary:   Allergy/Immunology Adverse Events   [ Time Frame: enrollment through study closeout or study withdrawal up to 9 months ]

7.  Secondary:   Dermatologic Adverse Events   [ Time Frame: enrollment to study close out or withdrawal up to 9 months ]

8.  Secondary:   Endocrinologic Adverse Events   [ Time Frame: enrollment to close out or study withdrawal up to 9 months ]

9.  Secondary:   Gastrointestinal Adverse Events   [ Time Frame: enrollment to study withdrawal or study close out up to 9 months ]

10.  Secondary:   Infectious Adverse Events   [ Time Frame: enrollment to study withdrawal or close out up to 9 months ]

11.  Secondary:   Metabolic or Laboratory AEs   [ Time Frame: enrollment to study withdrawal or close out up to 9 months ]

12.  Secondary:   Vascular Adverse Events   [ Time Frame: enrollment to study withdrawal or close out up to 9 months ]

13.  Secondary:   Constitutional Adverse Events   [ Time Frame: enrollment to study close out or withdrawal up to 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nancy M. Bauman MD, Principle Investigator
Organization: Childrens Research Institute
phone: 2024764270
e-mail: nbauman@cnmc.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nancy Bauman, Children's Research Institute
ClinicalTrials.gov Identifier: NCT00967226     History of Changes
Other Study ID Numbers: IRB 4502
NIH grant number 10179326
First Submitted: August 26, 2009
First Posted: August 27, 2009
Results First Submitted: March 14, 2014
Results First Posted: February 24, 2016
Last Update Posted: February 24, 2016