Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas
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|ClinicalTrials.gov Identifier: NCT01147601|
Recruitment Status : Terminated
First Posted : June 22, 2010
Results First Posted : July 5, 2017
Last Update Posted : July 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hemangioma Infant||Drug: topical 0.5% Timolol Drug: Control (placebo) group||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||August 2014|
Active Comparator: Topical 0.5% Timolol
Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
Drug: topical 0.5% Timolol
topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily
Placebo Comparator: Placebo
Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Drug: Control (placebo) group
Control (placebo) group
- 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 ]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 ]
- 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.
- The difference between the extent/size of the hemangioma as an outcome measure versus color changes.
- Frequency of adverse events (e.g. hypotension, behavioral changes, etc.), collected by the investigator and reported by the parents.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147601
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239-4501|
|Principal Investigator:||Alfons L. Krol, M.D.||Oregon Health and Science University|