Timolol Maleate Gel for the Treatment of Infantile Hemangioma

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of timolol maleate (TM) gel in subjects with superficial infantile hemangioma (IH) in the proliferative phase. The main question it aims to answer is: • The primary endpoint (success or failure) assessment was a centralized and independent qualitative assessment based on blinded comparison on B-ultrasonography results and photographs of IH at W24 from baseline. Researchers will compare TM gel to a placebo (a look-alike substance that contains no drug) to see if TM gel works to treat IH. Participants will: * Take the study drug 3 times daily (once in the morning, noon, and evening, respectively) for 24 weeks. * The family members of patients are instructed to bring the patients to the clinic for regular follow-up visits at Week 4 (W4), Week 12 (W12), and Week 24 (W24) of the treatment period. * Keep a diary of concomitant medications and adverse events.

Timeline

Start

2020-10-28

Primary completion

2022-06-21

Completion

2022-06-21

Drugs

Indications