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

Primary Purpose

Hemangioma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prednisolone (Corticosteroid)
Propranolol
Placebo
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemangioma

Eligibility Criteria

undefined - 9 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 0 to < 9months
  • Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma (IH) requiring medical treatment
  • IH patients whose parents desire medical treatment for the IH
  • Stable cardiac function

Exclusion Criteria:

  • IH patients over 9 months of age.
  • Hypersensitivity to propranolol
  • Untreated heart failure: If the patient has heart failure associated with the hemangioma, propranolol would be initiated after anti-congestive therapy and under observation as an in-patient.
  • Atrioventricular (AV) block
  • Resting heart < 2 SD of normal*(below)
  • Resting blood pressure < 2 SD of normal**(below)
  • Wolff-Parkinson-White syndrome (WPW)
  • History of unexplained syncope
  • Bronchial asthma
  • History of impaired renal or liver function
  • Diabetes mellitus

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A: Corticosteroid with Placebo

Group B: Corticosteroid with Propranolol

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Compare Changes in IH Size and Vascularity for the Two Treatment Groups
This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
Lesion Regression
measure of change in lesion area or volume

Secondary Outcome Measures

Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.
This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.
This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
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.
This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.

Full Information

First Posted
February 22, 2010
Last Updated
September 4, 2018
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01074437
Brief Title
Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Official Title
A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with corticosteroids and placebo. We hypothesize that a two-month treatment period with propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and vascularity when compared to corticosteroids used without propranolol for the same time period.
Detailed Description
Infantile hemangiomas (IH) are the most common head and neck pediatric tumors. Presence of these tumors can lead to complications of vision and airway compromise, bleeding and disfigurement. Medical treatment of these lesions has traditionally been focused on stopping new blood vessel growth with corticosteroids. Recent reports and our own experience have demonstrated that significant reduction in IH size and vascularity can also occur through the use of propranolol. Our initial experience with propranolol has demonstrated significant efficacy with fewer side effects than corticosteroids. Despite this experience, the standard of care for initial IH medical therapy remains corticosteroids. This Trial is a direct comparison of traditional IH therapy with corticosteroids to newer therapy with propranolol and corticosteroids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Corticosteroid with Placebo
Arm Type
Other
Arm Description
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.
Arm Title
Group B: Corticosteroid with Propranolol
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone (Corticosteroid)
Other Intervention Name(s)
Corticosteroids
Intervention Description
Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Propranolol hydrochloride (USP/EP) Oral Solution
Intervention Description
Oral liquid propranolol will be dosed Oral liquid propranolol will be dosed at 2 mg/kg/day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive drug, Inactive substance, Inactive medicine
Intervention Description
Liquid placebo will be given during the two month treatment trial.
Primary Outcome Measure Information:
Title
Compare Changes in IH Size and Vascularity for the Two Treatment Groups
Description
This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
Time Frame
1, 2, and 6 months after treatment initiation
Title
Lesion Regression
Description
measure of change in lesion area or volume
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.
Description
This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
Time Frame
1, 2, and 6 months after treatment initiation
Title
Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.
Description
This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
Time Frame
1, 2 and 6 months after treatment initiation
Title
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.
Description
This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
Time Frame
1, 2 and 6 months after treatment initiation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 0 to < 9months Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma (IH) requiring medical treatment IH patients whose parents desire medical treatment for the IH Stable cardiac function Exclusion Criteria: IH patients over 9 months of age. Hypersensitivity to propranolol Untreated heart failure: If the patient has heart failure associated with the hemangioma, propranolol would be initiated after anti-congestive therapy and under observation as an in-patient. Atrioventricular (AV) block Resting heart < 2 SD of normal*(below) Resting blood pressure < 2 SD of normal**(below) Wolff-Parkinson-White syndrome (WPW) History of unexplained syncope Bronchial asthma History of impaired renal or liver function Diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan A Perkins, DO
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21493392
Citation
Cushing SL, Boucek RJ, Manning SC, Sidbury R, Perkins JA. Initial experience with a multidisciplinary strategy for initiation of propranolol therapy for infantile hemangiomas. Otolaryngol Head Neck Surg. 2011 Jan;144(1):78-84. doi: 10.1177/0194599810390445.
Results Reference
background
PubMed Identifier
20674045
Citation
Truong MT, Perkins JA, Messner AH, Chang KW. Propranolol for the treatment of airway hemangiomas: a case series and treatment algorithm. Int J Pediatr Otorhinolaryngol. 2010 Sep;74(9):1043-8. doi: 10.1016/j.ijporl.2010.06.001. Epub 2010 Jul 31.
Results Reference
background

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

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