At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 105 enrolled
Drug / intervention
0.25% Timolol Maleate Gel Forming Solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy, Safety, and Pharmacokinetics of Timolol in Infants With Infantile Hemangioma (IH)
In Brief
A Phase 2 clinical trial evaluating 0.25% Timolol Maleate Gel Forming Solution and 0.5% Timolol Maleate Gel Forming Solution for Infantile Hemangioma. Completed, enrolled 105 participants across 12 sites.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5% doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfantile Hemangioma
CountriesUnited States
CollaboratorsThe Emmes Company, LLC, National Institutes of Health (NIH)
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartMay 2017
Primary CompletionOct 2020
TodayJul 2026
First PostedSep 26, 2016
Enrollment StartMay 5, 2017
Primary CompletionOct 20, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.8 years ago
Interventions
0.25% Timolol Maleate Gel Forming Solutiondrug
50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution
0.5% Timolol Maleate Gel Forming Solutiondrug
50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution