Propranolol and infantile hemangiomas: different routes of administration, a randomized clinical trial

Abstract

Oral propranolol has become the treatment of choice of infantile hemangiomas (IH)s. However, the safety of systemic propranolol is questioned. Topical therapy with 1% propranolol has been reported to be safe and effective. Intralesional (IL) administration may possibly allow safe delivery of higher drug dosages.

Aim: To assess the efficacy and safety of two locally administered routes of propranolol (topical and IL), in comparison with its systemic oral use in the treatment of IHs.

Patients and methods: 45 patients with IHs were randomly divided into 3 groups, A, B and C (n = 15 in each), receiving oral propranolol, 2 mg/kg/day, topical propranolol 1% ointment twice daily, IL propranolol, 1 mg of propranolol hydrochloride in 1 ml of injection once weekly, respectively. Follow up was done for 6 months after treatment was stopped.

Results: Excellent response was achieved in 9 patients in group A (60%), 3 in group B (20%) and 2 in group C (13.3%), (P value : 0.04). As regards safety, all 3 modalities proved safe with no major side effects apart from 1 patient in group A and 3 in group C who dropped out due to pain or inconvenience of therapy.

Conclusions: Further work is needed to establish clear guidelines and reach best formulations. Nevertheless, in properly selected patients with IHs, we recommend the usage of oral propranolol. Topically administered propranolol could be considered in patients at risk of potential side effects from oral administration. As IL application did not offer any more benefits, it could not be recommended.

Keywords: infantile hemangioma; intralesional; oral; propranolol; side effects; topical.