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Completed

NCT Number: NCT01685398

Topical Timolol for Superficial Infantile Hemangioma

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.

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Key information

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who is less than 2 years
  • Patient who has been diagnosed with superficial infantile hemangioma
  • The tumor which has been in proliferative or plateau phase
  • There is no indication for systemic treatment
  • Informed consent is obtained from the parent of the patient

Exclusion criteria

  • Patient who has the indication for systemic therapy
  • Patient who is treated by the other modality such as laser treatment
  • Patient who has underlying disease treated by beta blocker, corticosteroids, interferon, cyclophosphamide or vincristine
  • Patient who has history of hypersensitivity reaction to beta blocker, asthma, cardiac condition prove to heart block

Treatment and study plan

0.5% timolol maleate eye drop

Drug

normal saline

Drug

Other names: Saline

Primary outcomes

  1. Efficacy of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo

    Time frame: 6 months

    Percent changes in visual analogue scale of the lesion color and global assessment scale of the lesion after treatment

Secondary outcomes

  1. Side effects of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma

    Time frame: 6 months

    The side effects of 0.5% timolol maleate solution include bradycardia, dizziness, irritant contact dermatitis, allergic contact dermatitis, fatigue, nausea, diarrhea,and insomnia. To determine the side effects, investigators will monitor the vital signs of the patients every follow-up visit and ask the caretakers about the side effects. Furthermore, every patients will receive the dairy to record the frequency of drug usage and side effects found.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Treatment of Cutaneous Hemangioma of Infancy With Topical 0.5% Timolol Maleate Eye Drop Compared With Placebo in Pediatric Patients, Siriraj Hospital

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2012
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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