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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical 0.5% Timolol | Active Comparator | Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol. |
|
| Placebo | Placebo Comparator | Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical 0.5% Timolol | Drug | topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Treatment Group to Control Group Improvement Assessments |
|
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Inclusion Criteria:
Infants 1 month to 8 months of age with infantile hemangioma (IH) that are 3 cm or less on the scalp, trunk, or extremities.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfons L. Krol, M.D. | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239-4501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical 0.5% Timolol | Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol. topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily |
| FG001 | Placebo | Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily Control (placebo) group: Control (placebo) group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical 0.5% Timolol | Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol. topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%. | Posted | Count of Participants | Participants | at 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical 0.5% Timolol | Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol. topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alfons Krol | Oregon Health & Science University | 503-494-9993 | krola@ohsu.edu |
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| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D018324 | Hemangioma, Capillary |
| ID | Term |
|---|---|
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Control (placebo) group | Drug | Control (placebo) group |
|
| at 6 months |
Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Control (placebo) group: Control (placebo) group
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily Control (placebo) group: Control (placebo) group |
|
|
| Secondary | Compare Treatment Group to Control Group Improvement Assessments |
| Not Posted | at 6 months | Participants |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Placebo | Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily Control (placebo) group: Control (placebo) group | 0 | 1 | 0 | 1 |
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| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D003710 | Demography |
| D011154 | Population Characteristics |