Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas
Status: | Recruiting |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | Any |
Updated: | 4/2/2016 |
Start Date: | March 2010 |
Contact: | Alfons L. Krol, M.D. |
Email: | krola@ohsu.edu |
Phone: | 503 494 9333 |
Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study
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.
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.
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.
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:
1. Subjects with facial, genital, perianal, hand, finger, feet, or toe IH
2. Subjects with PHACES syndrome (proven) or suspected PHACES (plaque-like hemangioma on
the face awaiting imaging).
3. Subjects with IH measuring more than 3cm in size or ulcerated.
4. Children with a history of hypersensitivity to beta blockers.
5. Children with a personal history of asthma.
6. Children with known renal impairment.
7. Children with known cardiac conditions that may predispose to heart block
8. Personal history of hypoglycemia
9. Children on medications that may interact with beta blockers
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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