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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 of the skin;
    • Thin (<2 mm in thickness);
    • ≥0.5cm at its longest dimension and ≤10 cm2;
    • 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, hypertension, reactive airways disease).
  • IH that requires systemic therapy (defined by dynamic complication scale >3).
  • Infants with more than one hemangioma that requires therapy.
  • IH of the non-keratinized mucosa.
  • 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 airway disease (RAD).
  • Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Megha Tollefson, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20336662

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