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

Description

Multi-center, double-masked randomized, efficacy, safety and pharmacokinetic (PK) study.

Study Start Date

May, 05 2017

Estimated Completion Date

September 2018

Interventions

  • Drug: 0.5% Timolol Maleate Gel Forming Solution
  • Drug: 0.25% Timolol Maleate Gel Forming Solution

Study ID

Duke University -- Pro00068212

Status

Recruiting

Trial ID

NCT02913612

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

110

Sponsor

Duke University

Inclusion Criteria 1. Documented informed consent from legal guardian 2. 0-60 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): a. Superficial lesion in the dermis b. Thin <2 mm in thickness c. Small <5 cm2 d. 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 for an unrelated condition (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.

Gender

All

Ages

60 Days and younger

Accepts Healthy Volunteers

No

Study Locations and Contact Information (50)

Study Location Distance Name Phone Email
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Marilyn Liang MD 617-355-8937 marilyn.liang@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Marilyn Liang MD 617-355-8937 marilyn.liang@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Marilyn Liang MD 617-355-8937 marilyn.liang@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Marilyn Liang MD 617-355-8937 marilyn.liang@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Marilyn Liang MD 617-355-8937 marilyn.liang@childrens.harvard.edu
Columbia University Medical Center - New York, New York 181.2 miles Maria Garzon MD 212-305-5293 mcg2@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Maria Garzon MD 212-305-5293 mcg2@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Maria Garzon MD 212-305-5293 mcg2@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Maria Garzon MD 212-305-5293 mcg2@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Maria Garzon MD 212-305-5293 mcg2@cumc.columbia.edu
Childrens Hospital of Philadephia - Philadelphia, Pennsylvania 270.8 miles Jenna Streicher MD 215-590-2169 streicherj@email.chop.edu
Childrens Hospital of Philadephia - Philadelphia, Pennsylvania 270.8 miles Jenna Streicher MD 215-590-2169 streicherj@email.chop.edu
Childrens Hospital of Philadephia - Philadelphia, Pennsylvania 270.8 miles Jenna Streicher MD 215-590-2169 streicherj@email.chop.edu
Childrens Hospital of Philadephia - Philadelphia, Pennsylvania 270.8 miles Jenna Streicher MD 215-590-2169 streicherj@email.chop.edu
Childrens Hospital of Philadephia - Philadelphia, Pennsylvania 270.8 miles Jenna Streicher MD 215-590-2169 streicherj@email.chop.edu
Johns Hopkins Medical Center - Baltimore, Maryland 356.0 miles Kate Puttgen MD 410-955-5933 kateputtgen@jhmi.edu
Johns Hopkins Medical Center - Baltimore, Maryland 356.0 miles Kate Puttgen MD 410-955-5933 kateputtgen@jhmi.edu
Johns Hopkins Medical Center - Baltimore, Maryland 356.0 miles Kate Puttgen MD 410-955-5933 kateputtgen@jhmi.edu
Johns Hopkins Medical Center - Baltimore, Maryland 356.0 miles Kate Puttgen MD 410-955-5933 kateputtgen@jhmi.edu
Johns Hopkins Medical Center - Baltimore, Maryland 356.0 miles Kate Puttgen MD 410-955-5933 kateputtgen@jhmi.edu
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Adrienne Hammill MD 513-636-3184 adrienne.hammill@cchmc.org
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Adrienne Hammill MD 513-636-3184 adrienne.hammill@cchmc.org
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Adrienne Hammill MD 513-636-3184 adrienne.hammill@cchmc.org
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Adrienne Hammill MD 513-636-3184 adrienne.hammill@cchmc.org
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Adrienne Hammill MD 513-636-3184 adrienne.hammill@cchmc.org
Indiana University Health - Indianapolis, Indiana 805.0 miles Anita Haggstrom MD 317-944-7744 ahaggstr@iu.edu
Indiana University Health - Indianapolis, Indiana 805.0 miles Anita Haggstrom MD 317-944-7744 ahaggstr@iu.edu
Indiana University Health - Indianapolis, Indiana 805.0 miles Anita Haggstrom MD 317-944-7744 ahaggstr@iu.edu
Indiana University Health - Indianapolis, Indiana 805.0 miles Anita Haggstrom MD 317-944-7744 ahaggstr@iu.edu
Indiana University Health - Indianapolis, Indiana 805.0 miles Anita Haggstrom MD 317-944-7744 ahaggstr@iu.edu
Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles Sarah Chamlin MD 312-227-6475 schamlin@luriechildrens.org
Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles Sarah Chamlin MD 312-227-6475 schamlin@luriechildrens.org
Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles Sarah Chamlin MD 312-227-6475 schamlin@luriechildrens.org
Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles Sarah Chamlin MD 312-227-6475 schamlin@luriechildrens.org
Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles Sarah Chamlin MD 312-227-6475 schamlin@luriechildrens.org
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Beth Drolet MD 414-955-2818 bdrolet@mcw.edu
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Beth Drolet MD 414-955-2818 bdrolet@mcw.edu
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Beth Drolet MD 414-955-2818 bdrolet@mcw.edu
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Beth Drolet MD 414-955-2818 bdrolet@mcw.edu
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Beth Drolet MD 414-955-2818 bdrolet@mcw.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Megha Tollefson MD 507-284-3579 tollefson.megha@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Megha Tollefson MD 507-284-3579 tollefson.megha@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Megha Tollefson MD 507-284-3579 tollefson.megha@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Megha Tollefson MD 507-284-3579 tollefson.megha@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Megha Tollefson MD 507-284-3579 tollefson.megha@mayo.edu
The University of Texas Medical School at Houston - Houston, Texas 1,609.9 miles Adelaide Hebert MD 713-500-8266 adelaide.a.hebert@uth.tmc.edu
The University of Texas Medical School at Houston - Houston, Texas 1,609.9 miles Adelaide Hebert MD 713-500-8266 adelaide.a.hebert@uth.tmc.edu
The University of Texas Medical School at Houston - Houston, Texas 1,609.9 miles Adelaide Hebert MD 713-500-8266 adelaide.a.hebert@uth.tmc.edu
The University of Texas Medical School at Houston - Houston, Texas 1,609.9 miles Adelaide Hebert MD 713-500-8266 adelaide.a.hebert@uth.tmc.edu
The University of Texas Medical School at Houston - Houston, Texas 1,609.9 miles Adelaide Hebert MD 713-500-8266 adelaide.a.hebert@uth.tmc.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.