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Topical Timolol for Superficial Infantile Hemangioma

NCT01685398 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-09-21

No results posted yet for this study

Summary

Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. The characteristic natural history of this tumor is rapid growth in the first year of life and follows by spontaneous involution. However, it may cause cosmetic unacceptable. Early intervention in superficial IH may help to minimize the risk of residual aesthetic problems. Topical timolol, a non selective beta-blocker, is an emerging treatment which has been reported in efficacy and safety for the treatment of IH. However, the reported studies were case-series or small study. This study is a prospective double-blind,randomized-controlled study to evaluate the efficacy and safety of 0.5% timolol maleate solution for treatment in superficial IH. The patient will be treated with topical timolol for at least 6 months and instructed to 4 times daily apply 1-2 drop of timolol solution on the lesion and rub over the entire lesion with a finger. Photographs of the lesion will be taken at the baseline and every 1-month visit. Clinical evaluation of the treatment efficacy is carried out by 2 investigators independently to determine the change in lesion size and visual analogue scale of the lesion color. The main outcome is to evaluate the efficacy of 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo.

Conditions

  • Hemangioma

Interventions

DRUG

0.5% timolol maleate eye drop

DRUG

Normal saline

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Thailand

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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 NCT01685398 on ClinicalTrials.gov