Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:2/20/2019
Start Date:May 5, 2017
End Date:September 28, 2019
Contact:Chiara Melloni, MD, MHS
Email:chiara.melloni@duke.edu
Phone:919-668-8646

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Efficacy, Safety, and Pharmacokinetics of Timolol in Infants With Infantile Hemangioma (IH)

The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5%
doses.

Primary: Describe the efficacy of 0.25% and 0.5% topical timolol maleate GFS as assessed
through IH changes in volume. Secondary: Describe the safety and PK of topical timolol
maleate GFS for treatment of IH.

Inclusion Criteria

1. Documented informed consent from legal guardian

2. 0-84 days postnatal age at time of first study dose or when enrolled into the
non-intervention cohort.

3. Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must
include all of the following):

1. Superficial lesion in the dermis

2. Thin <2 mm in thickness

3. Small >=5 cm at its longest dimension and <=10cm2

4. Involves skin or keratinized mucosa

Exclusion Criteria

1. History of previous treatment with any pharmacologic or laser therapy for IH

2. Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac
arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot
(TOF), hypertension, reactive airways disease)

3. IH that requires systemic therapy (defined by dynamic complication scale >3)

4. IH of the non-keratinized mucosa

5. Infants with more than one hemangioma that requires therapy

6. Hemodynamically significant cardiovascular disease, as determined by the investigator

7. Known allergy to beta blockers or vehicle

8. Heart rate <100 beats per minute at screening visit

9. Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block

10. History of Reactive Airways Disease (RAD)

11. Any condition which would make the participant, in the opinion of the investigator
unsuitable for the study.
We found this trial at
12
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-955-2818
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Baltimore, Maryland 21231
Phone: 410-955-5933
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-3184
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-8937
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-6475
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Houston, Texas 77030
Phone: 713-500-8266
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Indianapolis, Indiana 46202
Phone: 317-944-7744
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Indianapolis, IN
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 603-650-3693
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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630 W 168th St
New York, New York
212-305-2862
Phone: 212-305-5293
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Philadelphia, Pennsylvania 19104
Phone: 215-590-2169
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Rochester, Minnesota 55905
Phone: 507-284-3579
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