Topical Timolol for Superficial Infantile Hemangioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01685398
First received: September 5, 2012
Last updated: November 26, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Hemangioma
Drug: 0.5% timolol maleate eye drop
Drug: Normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Efficacy of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percent changes in visual analogue scale of the lesion color and global assessment scale of the lesion after treatment


Secondary Outcome Measures:
  • Side effects of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 46
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01685398     History of Changes
Other Study ID Numbers: 088/2555(EC4)
Study First Received: September 5, 2012
Last Updated: November 26, 2012
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on October 19, 2014