Topical 0.5% Timolol Maleate for Superficial Infantile Hemangioma Treatment
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.
Saline Solution Treatment
+ Timolol Maleate Eye Drops Study
Neoplasms+1
+ Neoplasms by Histologic Type
+ Neoplasms, Vascular Tissue
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy 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