Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
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%.
at 6 months
Alfons L. Krol, M.D.
Oregon Health and Science University
United States: Institutional Review Board
|Oregon Health & Science University||Portland, Oregon 97201|