Status:
WITHDRAWN
Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Society for Pediatric Dermatology
Conditions:
Infantile Hemangiomas
Eligibility:
All Genders
1-8 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservat...
Detailed Description
Ulceration is the most common complication associated with infantile hemangiomas. Ulceration and the delay in wound healing places patients at risk for infection, bleeding, pain and permanent scarring...
Eligibility Criteria
Inclusion
- Infants weighing between 4-12kg
- Infants with corrected gestational age 44 weeks - 8 months of age
- Infant with an ulcerated hemangioma
- Informed consent
Exclusion
- Ulceration larger than 16cm2
- Ulcerated hemangioma with active bleeding or infection at time of enrollment
- Disease threatening hemangioma meeting criteria for oral propranolol
- Previous treatment with topical/oral corticosteroid or propranolol
- Medical history of congenital heart disease with decreased cardiac output, stroke/cerebral vasculopathy, active reactive airway disease or metabolic disorder
- History of an allergic reaction to Mupirocin or Timolol
- Currently taking medication that would interact with beta-blockers
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01408056
Start Date
February 1 2011
End Date
January 1 2014
Last Update
January 17 2014
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104