Completed

Topical 0.5% Timolol Maleate for Superficial Infantile Hemangioma Treatment

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Study Aim

This study aims to evaluate the effectiveness of a topical 0.5% Timolol Maleate solution in treating superficial infantile hemangiomas, comparing it to a placebo, by measuring changes in the lesion's color and overall appearance after treatment.

What is being tested

Saline Solution Treatment

+ Timolol Maleate Eye Drops Study

Drug
Who is being recruted

Neoplasms+1

+ Neoplasms by Histologic Type

+ Neoplasms, Vascular Tissue

Until 2 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorMahidol University
Last updated: September 21, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

Infantile hemangioma (IH) is a common type of benign vascular tumor found in children. This condition typically grows rapidly within the first year of life and then starts to shrink on its own. However, it may lead to cosmetic concerns. Early treatment of superficial IH can help minimize the risk of lasting aesthetic issues. One such treatment is topical timolol, a non-selective beta-blocker, which has shown promising results in terms of effectiveness and safety. However, most studies conducted so far have been small or case-specific. This study aims to evaluate the efficacy and safety of a 0.5% timolol maleate solution for treating superficial IH in a larger, more controlled setting. Participants in this study will receive topical timolol treatment for a minimum of 6 months. They will be instructed to apply 1-2 drops of the timolol solution onto the affected area four times a day, gently rubbing it over the entire lesion. Photographs of the lesion will be taken at the beginning of the study and during every monthly visit to monitor progress. Two independent investigators will evaluate the treatment's effectiveness by assessing changes in lesion size and color using a visual analogue scale. The primary outcome is to determine the efficacy of the 0.5% timolol maleate solution in treating infantile hemangioma compared to a placebo.

Principal SponsorMahidol University
Last updated: September 21, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 2 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Vascular TissueHemangioma

Criteria

5 inclusion criteria required to participate
Informed consent is obtained from the parent of the patient

Patient who has been diagnosed with superficial infantile hemangioma

Patient who is less than 2 years

The tumor which has been in proliferative or plateau phase

Show More Criteria

4 exclusion criteria prevent from participating
Patient who has history of hypersensitivity reaction to beta blocker, asthma, cardiac condition prove to heart block

Patient who has the indication for systemic therapy

Patient who has underlying disease treated by beta blocker, corticosteroids, interferon, cyclophosphamide or vincristine

Patient who is treated by the other modality such as laser treatment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
normal saline 1-2 drops put on the hemangioma lesion 4 times a day and rub over the entire lesion with a finger

Group II

Experimental
0.5% timolol maleate solution 1-2 drops put on the hemangioma lesion 4 times a day and rub over the entire lesion with a finger

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkoknoi, ThailandOpen Faculty of Medicine Siriraj Hospital Mahidol University in Google Maps
CompletedOne Study Center