Abstract: Objective To investigate the efficacy and safety of timolol maleate gel-forming solution with different concentrations for the treatment of superficial infantile hemangiomas (IHs). Methods From July 2012 to February 2013, patients aged from 1 to 6 months with superficial infantile hemangiomas were enrolled onto this study:a prospective, randomized, double-blind, controlled trial. Participants were randomly divided into 3 groups according to different concentration of timolol maleate gel-forming solution:group 1 (0.25%timolol gel), group 2 (0.5%timolol gel) and group 3 (1.0%timolol gel). Adverse effects and duration of the treatments were recorded. A visual analogue scale (VAS) was used to evaluate the efficacy of the drugs. Multiple logistic regression analysis was used to determine the independent correlation of each factor (e.g. age, gender, tumors location, the thickness of tumor, drug concentration, application frequency and duration of the treatment) and the efficacy. Results The mean VAS score was 30.94±32.97 for the patients treated by timolol gels with a total clinical efficacy of 62.3%. There were significant correlations between the VAS scores and the frequency&the duration of treatment (P<0.05). The main side effects were local skin reactions (2.9%) and mild wheezing (0.97%). Conclusion Timolol gel is safe and effective in the treatment for superficial IHs. Concentrations are not relevant for the treatment effect.

Key words: Timolol maleate gel-forming, Infantile hemangiomas, Efficacy, Safety