Topical Timolol Gel for the Treatment of Infantile Hemangiomas

Subjects will be randomly assigned to one of two groups: half to timolol maleate 0.5% gel
and the other half to the control solution. The study team as well as the parents of the
infants will be blinded as to the subjects' treatment.

Parents will be instructed to place 1 to 2 drops twice a day in the center of the
hemangioma. Subjects are expected to use the study drug as directed every day for a 4 month
period.

Subjects will be assessed at baseline, 2 weeks, 4 weeks, and every 4 weeks thereafter for a
total of 5 months. Physical exam, photographs to compare size and color intensity, and a
scale of improvement will be completed at each visit. Parents will complete a quality of
life questionnaire regarding their child's hemangioma and its impact on quality of life.

Subjects will be transferred to active timolol if there is evidence of significant worsening
at 4 weeks follow-up and beyond, as long as the patient is not at risk of imminent
ulceration. Patients who are crossed over to the active timolol arm will be removed from
study treatment at that time, but remain on study for follow-up.

Inclusion Criteria:

- Written informed permission for study participation and the use of the patient's
images are obtained from the patient's parent(s) or guardian(s),

- The patient is between 14 and 90 days of age at the time of enrollment,

- and a proliferating HOI not requiring systemic therapy is present anywhere on
the body with the largest diameter of at least 1.5 centimeters, and height not
greater than 1.5 cm. Multiple hemangiomas may be treated on same child, if the
hemangioma meets this criteria.

Exclusion Criteria:

- patients who are not otherwise generally healthy;

- patients with HOIs that are greater than 1.5 cm in height,

- at risk for imminent ulceration, life-threatening, function-threatening, or
ulcerated;

- patients who have previously received systemic, intra-lesional or topical
corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta
blockers;

- patients who have previously been treated for his/her HOI, including any surgical
and/or medical procedures;

- patients whose mothers have been breastfeeding the patient while also being treated
with beta-blockers, systemic corticosteroids, vincristine or alpha-interferon;

- patients who have previously experienced any anaphylactic reactions; patients with an
unclear diagnosis of HOI;

- patients participating in another clinical study or living in the same household as
an infant already participating in this study;

- patients born prematurely who have not yet reached his/her term equivalent age; and
patients with parent(s) or guardian(s) who cannot be contacted by telephone in case
of emergency.