Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)

• Status: Withdrawn
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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 conservative management with topical antibiotic.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborator: Society for Pediatric Dermatology
• Treatments: Mupirocin; Pharmaceutical Solutions; Timolol

Criteria

Inclusion Criteria:

• Infants weighing between 4-12kg

• Infants with corrected gestational age 44 weeks - 8 months of age

• Infant with an ulcerated hemangioma

• Informed consent

Exclusion Criteria:

• 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