Infantile hemangiomas not affected by topical timolol

Topical timolol, while well tolerated, offered little efficacy in treating early proliferative infantile hemangioma, according to a study.

“Infantile hemangiomas (IHs) are the most common benign tumors of infancy,” Fania Z. Muñoz-Garza, MD, of the dermatology service, Hospital de la Santa Creu i Sat Pau, Barcelona, Spain, and colleagues wrote. “In recent years, timolol maleate, a nonselective beta-adrenergic drug, has been used as a topical agent to treat superficial IHs. ... We hypothesized that the use of topical timolol in the early proliferative phase would be even more effective for preventing hemangioma growth and the need for oral propranolol treatment.”

The prospective, randomized, double-blind, placebo-controlled phase 2a clinical trial included 69 patients aged 10 to 60 days with focal or segmental IHs. Subjects were randomly assigned to receive either two drops of timolol maleate solution 0.5% every 12 hours for 24 weeks or two drops of saline-based placebo. Fifty-seven patients completed 24 weeks of treatment.

Eleven patients (42%) in the treatment group had complete or nearly complete IH resolution at 24 weeks compared with 11 patients (36%) in the placebo group, which was not a statistically significant difference. Odds ratio of complete or almost complete response compared with no response was 1.33 (95% CI, 0.45-3.89), the study said.

“Difference in resolution rate with use of timolol was not significant compared with placebo,” the authors wrote.