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

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ClinicalTrials.gov Identifier: NCT01074437
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : February 24, 2010
Results First Posted : September 26, 2013
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
Jonathan Perkins, Seattle Children's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Hemangioma
Interventions: Drug: Prednisolone (Corticosteroid)
Drug: Propranolol
Drug: Placebo

  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
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

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 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1

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.  

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.  

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.  

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.  


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


  More Information

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
First Submitted: February 22, 2010
First Posted: February 24, 2010
Results First Submitted: July 22, 2013
Results First Posted: September 26, 2013
Last Update Posted: January 13, 2014