Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)
Status and phase
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Treatments
Details and patient eligibility
About
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.
Full 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. Currently, the care of ulcerated hemangiomas is extremely difficult and patients are often subject to multiple treatment modalities.
In the past two years, the leading advance in the treatment of hemangiomas has been the use of the non-selective, oral beta-blocker propranolol to arrest growth and promote involution of hemangiomas. Recent literature also suggests beta-blockers may have a role in helping ulcerated wounds re-epithelialize.
The use of a topical non-selective beta-blocker on isolated ulcerated hemangiomas may promote early healing and reduce the number of complications associated with ulceration. Investigation is needed to explore the safety and tolerability of applying a topical beta-blocker on an ulcerated hemangioma and whether topical beta-blockade may be more efficacious than conservative care with topical antibiotics.
In this study, infants will be randomized to either receive a topical antibiotic (topical mupirocin 2% ointment twice per day) or a topical beta-blocker (Timolol 0.5% Gel Forming Solution) according to a dose-escalation schedule. Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed. Photographs and safety and efficacy measurements will be taken at each visit to assess response to therapy.
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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