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

NCT02913612 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-03-12

Study results available
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Summary

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

Conditions

  • Infantile Hemangioma

Interventions

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

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • Kanecia Obie Zimmerman

    lead OTHER

Principal Investigators

  • Kanecia Zimmerman, MD, MHS · Duke Clinical Research Institute

  • Kristin Holland, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
84 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2020-10-20
Completion
2020-10-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02913612 on ClinicalTrials.gov