Objective: Infantile hemangiomas (IHs) are the most common vascular tumors of infancy. Oral propranolol has achieved great success in treating IHs since 2008. To minimize the systemic side events caused by oral administration of propranolol, topical timolol started to be applied in the treatment of IHs, especially for superficial lesions.Methods: We treated 724 children with superficial IHs using oral propranolol or topical timolol, and investigated the efficacy and safety of the two treatment patterns.Results: Both oral propranolol and topical timolol achieved a satisfactory therapeutic outcome, with an effective response rate of 97 and 96.4%, respectively. No significant differences in visual analog scale (VAS) improvement between the two groups were observed. Occurrence rate of systemic adverse events for patients treated with oral propranolol (3.9%) was significantly higher than that for patients treated with topical timolol (0%). Clinical response was not associated with gender, duration of treatment, lesion location, lesion size, gestational age, and progesterone use during pregnancy, but closely associated with age at treatment initiation, which indicated that younger age at treatment initiation predicted for a better regression rate.Conclusions: We recommend that topical timolol instead of oral propranolol could be the first-line therapy for superficial IHs because of its good efficacy and improved safety.

The therapeutic options for infantile hemangiomas (IHs) have been greatly altered since the introduction of oral propranolol for successful treatments of IHs. Recently, there is an increase in the application of topical timolol maleate for treating superficial IHs. In the present study, we developed a new formulation of timolol maleate 0.5% hydrogel and treated 321 patients with superficial IHs to evaluate its efficacy and safety in the treatment of superficial IHs. This new timolol hydrogel was applied three times daily with a mean duration of 7.1 months. Response to treatment was assessed according to cosmetic improvement by using visual analog scale (VAS). The average VAS improvement after treatment was 76.4, with 126 patients (39.3%) achieving excellent responses, 159 patients (49.5%) achieving good responses, 33 patients (10.3%) achieving fair responses, and three patients (0.9%) achieving poor responses. Age at treatment initiation (P = 0.0349) and lesion thickness (P = 0.0147) were significantly associated with therapeutic efficacy. No severe side effects were observed in all patients. In conclusion, this new topical timolol maleate 0.5% hydrogel appears to be a proper candidate for treating superficial IHs, and our study provides supportive evidence and experience of topical timolol maleate in treating superficial IHs.