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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01074437 |
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Date of registration:
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22/02/2010 |
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Primary sponsor: |
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Public title:
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Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
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Scientific title:
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A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH) |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01074437 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jonathan A Perkins, DO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seattle Children's Hospital |
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Key inclusion & exclusion criteria
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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.
- AV block
- Resting heart < 2SD of normal*(below)
- Resting blood pressure < 2SD of normal**(below)
- WPW (Wolff-Parkinson-White syndrome)
- History of unexplained syncope
- Bronchial asthma
- History of impaired renal or liver function
- Diabetes mellitus
Age minimum:
N/A
Age maximum:
9 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemangioma
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Intervention(s)
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Drug: Placebo
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Drug: Prednisolone (Corticosteroid)
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Drug: Propanolol
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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