Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01685398
Study type Interventional
Source Mahidol University
Contact
Status Completed
Phase Phase 3
Start date September 2012
Completion date March 2023

See also
  Status Clinical Trial Phase
Withdrawn NCT00974129 - A Study of CCCTC-binding Factor (CTCF) in Infantile Hemangiomas N/A
Completed NCT00374335 - Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas N/A
Recruiting NCT03331744 - Clinical Characteristics of Infantile Hemangioma
Completed NCT02342275 - Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma Phase 3
Completed NCT00433940 - Immune Suppression Of Infants Treated With Steroids N/A
Completed NCT04065217 - The Effectiveness of Diode Laser 980-nm in Iraqi Face Hemangioma: a Randomized Within Patients Trial N/A
Terminated NCT01743885 - Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma Phase 3
Terminated NCT00555464 - Clinical Trial of Vincristine vs. Prednisolone for Treatment of Complicated Hemangiomas Phase 2
Completed NCT00394888 - Hemangioma Associated With High Rates of Morbidity N/A
Completed NCT05327309 - Role of Propranolol as Compared to Bleomycin in Management of Hemangioma N/A
Completed NCT02145884 - Topical Timolol Gel for the Treatment of Infantile Hemangiomas Phase 2
Completed NCT04077515 - Safety and Efficacy of Low-dose Sirolimus to Kaposiform Hemangioendothelioma Phase 4
Completed NCT02731287 - Topical Timolol for Infantile Hemangioma in Early Proliferative Phase Phase 2
Recruiting NCT01147601 - Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas Phase 0
Completed NCT01908972 - The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma Phase 4
Completed NCT00540566 - Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Completed NCT00001417 - Direct Injection of Alcohol for the Treatment of Spinal Tumors N/A
Completed NCT00004436 - Randomized Study of Hormonal Regulation of Infantile Hemangioma N/A
Recruiting NCT02496013 - Clinical Translation of a Novel Albumin-Binding PET Radiotracer 68Ga-NEB Phase 1
Completed NCT01072045 - Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma Phase 2