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

Completed · Phase 2

Conditions studied: Infantile Hemangioma

In brief

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

Key facts

Study ID

NCT02913612

Run by

Kanecia Obie Zimmerman

People needed

105

Starts

2017-05-05

Expected to finish

2020-10-20

Last updated by the study team

2024-03-12

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented informed consent from legal guardian
• 0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort.
• Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following):
• Superficial lesion in the dermis
• Thin <2 mm in thickness
• Small >=5 cm at its longest dimension and <=10cm2
• Involves skin or keratinized mucosa

You may not qualify if…

• History of previous treatment with any pharmacologic or laser therapy for IH
• 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)
• IH that requires systemic therapy (defined by dynamic complication scale >3)
• IH of the non-keratinized mucosa
• Infants with more than one hemangioma that requires therapy
• Hemodynamically significant cardiovascular disease, as determined by the investigator
• Known allergy to beta blockers or vehicle
• Heart rate <100 beats per minute at screening visit
• Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block
• History of Reactive Airways Disease (RAD)
• Any condition which would make the participant, in the opinion of the investigator unsuitable for the study.

Where it is running

• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Indiana University Health — Indianapolis, Indiana, United States
• Johns Hopkins Medical Center — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Columbia University Medical Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadephia — Philadelphia, Pennsylvania, United States
• The University of Texas Medical School at Houston — Houston, Texas, United States
• DCOL Center for Clinical Research — Longview, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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