NCT06677853

Timolol Maleate Gel for the Treatment of Infantile Hemangioma

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Timolol Maleate Gel in the Treatment of Proliferating Superficial Infantile Hemangioma

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Auson Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 35 Days – 150 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Infantile Hemangioma

Interventions

Type	Name	Description
DRUG	Timolol Maleate Gel+Placebo	Subjects were applied with the 0.5% timolol maleate gel at the affected area twice a day, and with the placebo once a day for 24 weeks.
DRUG	Timolol Maleate Gel	Subjects were applied with the 0.5% timolol maleate gel at the affected area 3 times a day for 24 weeks.
DRUG	Placebo	Subjects were applied with placebo at the affected area 3 times a day for 24 weeks.

Timeline

• Start date: 2020-10-28
• Primary completion: 2022-06-21
• Completion: 2022-06-21
• First posted: 2024-11-07
• Last updated: 2024-11-07

Locations

8 sites across 1 country: China