Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas
Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemangioma; Infant
Intervention: topical 0.5% Timolol (Drug); Control (placebo) group (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s):
Alfons L. Krol, M.D., Principal Investigator, Affiliation: Oregon Health and Science University
Overall contact:
Alfons L. Krol, M.D., Phone: 503 494 9333, Email: krola@ohsu.edu
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.
Clinical Details
Official title: Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Compare treatment group to control group improvement assessments
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.
Eligibility
Minimum age: 1 Month.
Maximum age: 8 Months.
Gender(s): Both.
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:
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
Locations and Contacts
Alfons L. Krol, M.D., Phone: 503 494 9333, Email: krola@ohsu.edu
Oregon Health & Science University, Portland, Oregon 97239-4501, United States; Recruiting
Alfons L. Krol, M.D., Phone: 503-494-9993, Email: krola@ohsu.edu
Lindsay K. Severson, B.A., CCRC, Phone: 503 494 6009, Email: seversol@ohsu.edu
Alfons L. Krol, M.D., Principal Investigator
Additional Information
Starting date: March 2010
Last updated: June 18, 2010
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