Back to resultsTopical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas
Primary Purpose
Hemangioma, Infant
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
topical 0.5% Timolol
Control (placebo) group
Sponsored by
About this trial
This is an interventional treatment trial for Hemangioma focused on measuring topical 0.5% Timolol, infantile hemangioma (IH)
Eligibility Criteria
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:
- Subjects with facial, genital, perianal, hand, finger, feet, or toe IH
- Subjects with PHACES (plaque-like hemangioma on the face awaiting imaging) syndrome (proven) or suspected PHACES .
- Subjects with IH measuring more than 3cm in size or ulcerated.
- Children with a history of hypersensitivity to beta blockers.
- Children with a personal history of asthma.
- Children with known renal impairment.
- Children with known cardiac conditions that may predispose to heart block
- Personal history of hypoglycemia
- Children on medications that may interact with beta blockers
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Topical 0.5% Timolol
Placebo
Arm Description
Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
Compare Treatment Group to Control Group Improvement Assessments
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.
Full Information
NCT ID
NCT01147601
First Posted
June 14, 2010
Last Updated
April 19, 2017
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01147601
Brief Title
Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas
Official Title
Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma, Infant
Keywords
topical 0.5% Timolol, infantile hemangioma (IH)
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical 0.5% Timolol
Arm Type
Active Comparator
Arm Description
Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Intervention Type
Drug
Intervention Name(s)
topical 0.5% Timolol
Intervention Description
topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily
Intervention Type
Drug
Intervention Name(s)
Control (placebo) group
Intervention Description
Control (placebo) group
Primary Outcome Measure Information:
Title
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.
Description
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%.
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Compare Treatment Group to Control Group Improvement Assessments
Description
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.
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Subjects with facial, genital, perianal, hand, finger, feet, or toe IH
Subjects with PHACES (plaque-like hemangioma on the face awaiting imaging) syndrome (proven) or suspected PHACES .
Subjects with IH measuring more than 3cm in size or ulcerated.
Children with a history of hypersensitivity to beta blockers.
Children with a personal history of asthma.
Children with known renal impairment.
Children with known cardiac conditions that may predispose to heart block
Personal history of hypoglycemia
Children on medications that may interact with beta blockers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfons L. Krol, M.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-4501
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas
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