NCT02913612

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Kanecia Obie Zimmerman · Academic / Other
• Sex: All
• Age: 84 Days
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary: Describe the efficacy of 0.25% and 0.5% topical timolol maleate Gel-forming solution (GFS) as assessed through Infantile Hemangioma (IH) changes in volume. Secondary: Describe the safety of topical timolol maleate GFS for treatment of IH.

Conditions

• Infantile Hemangioma

Interventions

Type	Name	Description
DRUG	0.25% Timolol Maleate Gel Forming Solution	50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution
DRUG	0.5% Timolol Maleate Gel Forming Solution	50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution

Timeline

• Start date: 2017-05-05
• Primary completion: 2020-10-20
• Completion: 2020-10-20
• First posted: 2016-09-26
• Last updated: 2024-03-12
• Results posted: 2022-11-15

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study