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

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Jonathan Perkins, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01074437
First received: February 22, 2010
Last updated: December 11, 2013
Last verified: December 2013
Results First Received: July 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hemangioma
Interventions: Drug: Prednisolone (Corticosteroid)
Drug: Propranolol
Drug: Placebo

  Participant Flow
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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
Group A: Corticosteroid With Placebo Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
Group B: Corticosteroid With Propranolol Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.

Participant Flow:   Overall Study
    Group A: Corticosteroid With Placebo     Group B: Corticosteroid With Propranolol  
STARTED     4     5  
COMPLETED     4     5  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Group A: Corticosteroid With Placebo Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
Group B: Corticosteroid With Propranolol Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
Total Total of all reporting groups

Baseline Measures
    Group A: Corticosteroid With Placebo     Group B: Corticosteroid With Propranolol     Total  
Number of Participants  
[units: participants]
  4     5     9  
Age  
[units: participants]
     
<=18 years     4     5     9  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  0.2  ± 0.1     0.2  ± 0.1     0.2  ± 0.1  
Gender  
[units: participants]
     
Female     3     3     6  
Male     1     2     3  
Region of Enrollment  
[units: participants]
     
United States     4     5     9  



  Outcome Measures

1.  Primary:   Lesion Regression   [ Time Frame: 12 months ]

2.  Primary:   Compare Changes in IH Size and Vascularity for Subjects Randomized to Receive Initial Treatment With Corticosteroid-only Therapy Versus Combination Therapy With Corticosteroids Plus Propranolol   [ Time Frame: 1, 2, and 6 months after treatment initiation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.   [ Time Frame: 1, 2, and 6 months after treatment initiation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.   [ Time Frame: 1, 2 and 6 months after treatment initiation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  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.   [ Time Frame: 1, 2 and 6 months after treatment initiation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jonathan Perkins, Prinicipal Investigator
Organization: Seattle childrens research institute
phone: 206-987-1927
e-mail: jonathan.perkins@seattlechildrens.org


Publications:

Responsible Party: Jonathan Perkins, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01074437     History of Changes
Other Study ID Numbers: 12901
Study First Received: February 22, 2010
Results First Received: July 22, 2013
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board