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The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas

Phase 2
1 Month
8 Months
Open (Enrolling)
Infantile Hemangiomas

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Trial Information

The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Wound Re-epithelization

Outcome Time Frame:

At 3 months

Safety Issue:


Principal Investigator

Albert C. Yan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital of Philadelphia, Chair of Pediatric Dermatology


United States: Institutional Review Board

Study ID:




Start Date:

February 2011

Completion Date:

June 2013

Related Keywords:

  • Infantile Hemangiomas
  • Hemangioma
  • Infantile Hemangioma
  • Ulcerated Hemangioma
  • Timolol
  • Beta blocker
  • Vascular anomaly
  • Hemangioma
  • Ulcer
  • Hemangioma, Capillary



Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104