NCT01147601

Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas

Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 1 Month – 8 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.

Detailed description

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.

Conditions

• Hemangioma
• Infant

Interventions

Type	Name	Description
DRUG	topical 0.5% Timolol	topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily
DRUG	Control (placebo) group	Control (placebo) group

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-10-01
• Completion: 2014-08-01
• First posted: 2010-06-22
• Last updated: 2017-07-05
• Results posted: 2017-07-05

Locations

1 site across 1 country: United States