Efficacy and Safety of Topical Timolol in Localized Superficial Hemangiomas: A Prospective Controlled Open-label Study

Abstract Background: Infantile hemangiomas (IHs) are common vascular tumors of infancy that often regress spontaneously. However, early treatment may be required to prevent complications. This study evaluated the efficacy and safety of topical timolol maleate 0.5% in superficial and predominantly superficial IHs compared with conservative management. Methodology: In this prospective controlled study conducted over 3 years, 186 children with IHs were allocated to receive either topical timolol 0.5% twice daily ( n = 93) or a bland moisturizer ( n = 93) for 6 months. Clinical response was assessed based on reduction in lesion size, color, and elevation. Statistical significance was set at P < 0.05. Results: At 6 months, an excellent response was achieved in 65.6% of the timolol group compared with 27.8% of controls ( P < 0.001). Mean lesion surface area decreased by 63.2% with timolol versus 29.4% with moisturizer ( P < 0.001). Visible reduction in erythema was significantly greater in the timolol group ( P < 0.001). No serious local or systemic adverse effects were observed. Conclusion: Topical timolol 0.5% is a safe and effective treatment for superficial IHs, demonstrating significantly greater regression than conservative management.