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

Hemangioma Clinical Trial

Official title:

A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01074437
• Other study ID #: 12901
• Status: Terminated
• Phase: Phase 2
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: September 2018
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Drug:
• Prednisolone (Corticosteroid)
Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks.
• Propranolol
Oral liquid propranolol will be dosed Oral liquid propranolol will be dosed at 2 mg/kg/day.
• Placebo
Liquid placebo will be given during the two month treatment trial.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1, 2, and 6 months after treatment initiation
Primary	Lesion Regression	measure of change in lesion area or volume	12 months
Secondary	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.	1, 2, and 6 months after treatment initiation
Secondary	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.	1, 2 and 6 months after treatment initiation
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.	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.	1, 2 and 6 months after treatment initiation