Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas

• Proportion of subjects in treatment group compared to placebo group with at least 75% improvement in the extent of the hemangioma as compared to baseline photos. [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  This will be generated by asking each of the assessors to score the improvement using a visual analog scale (VAS) assessing the decrease in size of hemangioma by comparing photographs at different times of treatment. The assessors will score this improvement into one of the following categories: 0-24%, 25-49%, 50-74%, >75%.
  
  

• Compare treatment group to control group improvement assessments [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  1. The proportion of subjects in the treatment group as compared to the placebo control group with at least 50% improvement in the extent of the hemangioma.
  2. The difference between the extent/size of the hemangioma as an outcome measure versus color changes.
  3. Frequency of adverse events (e.g. hypotension, behavioral changes, etc.), collected by the investigator and reported by the parents.
  
  

At the first visit, subjects will fill out a questionnaire that asks about the child's history and the hemangioma. Photographs and measurements will be taken at this and each subsequent visit. At the first visit, subjects will have a physical exam, including vital signs, height and weight. An EKG will also be done. Study drug will be dispensed and instructions given. Half of the subjects will receive a placebo. This is a blinded randomized study. Follow-up visits will be weekly for the first two weeks (three visits total including the first visit), then monthly until the study is over. Photographs and measurements will again be taken at each visit. Subjects will be asked to evaluate the size and the color of the hemangioma against the first photographs and fill out forms regarding any changes in behavior and asked about any side effects.