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Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)

NCT01408056 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-01-17

No results posted yet for this study

Summary

The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.

Conditions

  • Infantile Hemangiomas

Interventions

DRUG

Timolol 0.5% Gel Forming Solution (GFS)

Dose-based escalation schedule for topical application: 4-8 kg: Day 0-7: 1 drop every other day; Day 7-14: 1 drop daily; Day 14 - Day 60: 1 drop twice per day 8-12 kg: Day 07: 1 drop daily; Day 7-14: 1 drop twice per day; Day 14 - Day 60: 2 drops twice per day

DRUG

Mupirocin 2% Ointment

Topical application twice per day for 60 days

Sponsors & Collaborators

Principal Investigators

  • Albert C. Yan, MD · Children's Hospital of Philadelphia, Chair of Pediatric Dermatology

  • Vikash S. Oza, MD · Children's Hospital of Philadelphia, Attending Physician

  • Patrick McMahon, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01408056 on ClinicalTrials.gov