Nadolol Versus Propranolol in Children With Infantile Hemangiomas

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Infantile Hemangioma

Treatments: Drug: Nadolol; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT02505971

1000048673

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of oral propranolol versus nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled, double-blinded study.

Full description

The study objective is to compare the efficacy and safety of oral propranolol in comparison with oral nadolol in patients with IH. Patients will be randomly assigned to either propranolol or dose equivalent nadolol. The duration of the study will be 24 weeks, however, patient will be monitored for up to 1 year post study enrolment. Both efficacy and safety will be closely monitored and captured.

Enrollment: 74 patients

Sex: All

Ages: 1 to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1-6 months corrected age

• Written parental informed consent

• At least one of the following:

  • Size: hemangioma >1.5 cm on the face or >3 cm on other body parts
  • Causing or with potential for functional impairment (e.g. amblyogenic IH, ulcerated hemangioma)
  • Causing or with potential for cosmetic disfigurement (e.g. nasal tip, glabella location)

Exclusion criteria

• Contraindications to beta-blockers

  • Hypotension
  • Bradycardia
  • Hypoglycemia
  • Cardiac disease associated with decreased ejection fraction and/or > second degree heart block
  • Bronchospasm (including bronchial asthma)
  • Allergic rhinitis

• Corrected gestational age less than 1 month at screening

• Patients with PHACES cerebral arteriopathy at risk of stroke

• Patients and/or breastfeeding mothers receiving treatment with anti-arrhythmic agents, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators, hypoglycemic agents, neuroleptics, antiacids, benzodiazepines, thyroxine, warfarin

• Patients treated with an oral beta-blocker or other agent (e.g. systemic steroids, vincristine) within 2 weeks from randomization

• Patients treated with topical timolol within 1 week from randomization

• Vascular tumors other than infantile hemangioma (e.g. pyogenic granuloma, hemangioendothelioma)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups

Nadolol group

Active Comparator group

Description:

40 study participants will take Nadolol (oral liquid suspension)

Treatment:

Drug: Nadolol

Propranolol group

Active Comparator group

Description:

40 study paticipants will take Propranolol (oral liquid suspension)

Treatment:

Drug: Propranolol