Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)

Phase 2 Completed 105 enrolled Kanecia Obie Zimmerman National Institutes of Health (NIH) · collab The Emmes Company, LLC · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5% doses.

Timeline

Start: 2017-05-05
Primary completion: 2020-10-20
Completion: 2020-10-20

Outcome

Met primary endpoint

registry analysis (superiority test); 0.5% Timolol Treatment vs Non-Intervention Group; p = 0.0205; Odds Ratio, log 2.65 (95% CI 1.12 to 6.26); Fisher Exact NCT02913612 ↗

Publications

Background Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C; Pediatric Trials Network Steering Committee (See Acknowledgments for a listing of committee members.). Systemic timolol exposure following topical application to infantile hemangiomas. J Am Acad Dermatol. 2020 Mar;82(3):733-736. doi: 10.1016/j.jaad.2019.02.029. Epub 2019 Feb 18. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Timolol	Other / unclassified	0.25 %	Topical
Subject	Timolol	Other / unclassified	0.5 %	Topical