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Summary

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

Conditions

Infantile Hemangioma

Recruitment Status

Completed

Detailed Description

Primary: Describe the efficacy of 0.25% and 0.5% topical timolol maleate Gel-forming solution (GFS) as assessed through Infantile Hemangioma (IH) changes in volume. Secondary: Describe the safety of topical timolol maleate GFS for treatment of IH.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

Intervention

Intervention Type

Intervention Name

Drug

0.25% Timolol Maleate Gel Forming Solution

Drug

0.5% Timolol Maleate Gel Forming Solution

Phase

Phase 2

Gender

All

Min Age

N/A

Max Age

84 Days

Download Date

March 12, 2024

Principal Investigator

Kanecia Obie Zimmerman

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH) NCT02913612