We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate 0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas.
Subjects will be assigned to open label timolol maleate 0.5%. 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 who have evidence of worsening would be removed from the study and transferred to the clinic for evaluation and treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Apply timolol gel 1-2 drops twice a day to lesion
Pediatric and Adolescent Dermatology, Rady Children's Hospital/University of California, San Diego
San Diego, California, United States
Change in size of hemangioma
At each visit, the size of the IH is assessed in three dimensions (length, width, and height) in cm.
Time frame: Baseline, week 2, 4, 8, 12, 16
Change in color of hemangioma
At each visit, the color intensity (e.g., barely perceptible; pale pink or mottled pink/red; red with central pallor; dull red; bright red) of the IH is assessed on a 6 point scale.
Time frame: Baseline, week 2, 4, 8, 12, 16
Measure the extent of systemic absorption and the factors which influence absorption
A heel stick blood sample is collected to assess for systemic absorption.
Time frame: week 2
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