Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-02-05 @ 5:30 PM
Study NCT ID:
NCT02913612
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2016-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)
Sponsor:
Kanecia Obie Zimmerman
Organization:
Study Overview
Official Title:
Efficacy, Safety, and Pharmacokinetics of Timolol in Infants With Infantile Hemangioma (IH)
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIM01
Brief 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.
Secondary: Describe the safety of topical timolol maleate GFS for treatment of IH.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: