Clinical trial NCT01074437: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hemangioma
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 9
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Compare Changes in IH Size and Vascularity for the Two Treatment Groups
timeFrame: 1, 2, and 6 months after treatment initiation
measure: Lesion Regression
timeFrame: 12 months
Secondary outcomes:
measure: Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.
timeFrame: 1, 2, and 6 months after treatment initiation
measure: Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.
timeFrame: 1, 2 and 6 months after treatment initiation
measure: 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.
timeFrame: 1, 2 and 6 months after treatment initiation
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Jonathan A Perkins, DO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.