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Topical Timolol for Superficial Infantile Hemangioma

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ClinicalTrials.gov Identifier: NCT01685398
Recruitment Status : Unknown
Verified June 2012 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : September 14, 2012
Last Update Posted : November 27, 2012
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief 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.

Condition or disease Intervention/treatment Phase
Hemangioma Drug: 0.5% timolol maleate eye drop Drug: Normal saline Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Cutaneous Hemangioma of Infancy With Topical 0.5% Timolol Maleate Eye Drop Compared With Placebo in Pediatric Patients, Siriraj Hospital
Study Start Date : September 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: normal saline
normal saline 1-2 drops put on the hemangioma lesion 4 times a day and rub over the entire lesion with a finger
Drug: Normal saline
Other Name: Saline
Experimental: 0.5% timolol maleate eye drop
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
Drug: 0.5% timolol maleate eye drop



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685398


Contacts
Contact: Rattanavalai Nitiyarom, MD 6624195678 rattanavalai.nit@mahidol.ac.th

Locations
Thailand
Faculty of Medicine Siriraj Hospital Mahidol University Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Rattanavalai Nitiyarom, MD    6624195678      
Principal Investigator: Rattanavalai Nitiyarom, MD         
Sponsors and Collaborators
Mahidol University

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01685398     History of Changes
Other Study ID Numbers: 088/2555(EC4)
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Ophthalmic Solutions
Tetrahydrozoline
Timolol
Maleic acid
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors