PTN timolol study completes patient enrollment

The Pediatric Trials Network (PTN) has enrolled the last patient in its Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants with Infantile Hemangioma (TIM01) study.

In the study, approximately 110 participants will be randomized to either 0.25% or 0.5% timolol for 180 days to determine the most appropriate dosing level for children younger than three months old.

Timolol is a beta blocker that has increasingly been used for the treatment of Infantile Hemangiomas (IH), commonly called “strawberry” birthmarks, on infants’ skin. The popularity of timolol is likely due to its perceived safety as a topical drug. However, little is known regarding the safety of topical timolol’s use.

To learn more about the PTN timolol study, visit the timolol study page and the timolol highlight on clinicaltrials.gov.

Additional updates will be shared upon the conclusion of the study in 2020.

Systemic Timolol Exposure Following Topical Application to Infantile Hemangiomas

Journal of the American Academy of Dermatology • February 2019.

Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C; Pediatric Trials Network Steering Committee.

Off-label ophthalmic timolol has been rapidly adopted for treatment of infantile hemangioma since topical application of beta-blockers was presumed to have an improved safety profile compared to oral administration. We examined timolol plasma concentrations in children receiving ophthalmic preparations applied to skin hemangiomas.

Access article on PubMed.