Topical Timolol for Superficial Infantile Hemangioma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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 |
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| Contact: Rattanavalai Nitiyarom, MD | 6624195678 | rattanavalai.nit@mahidol.ac.th |
| Thailand | |
| Faculty of Medicine Siriraj Hospital Mahidol University | Recruiting |
| Bangkoknoi, Bangkok, Thailand, 10700 | |
| Contact: Rattanavalai Nitiyarom, MD 6624195678 | |
| Principal Investigator: Rattanavalai Nitiyarom, MD | |
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 Hemangioma, Capillary Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Timolol Tetrahydrozoline 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 Nasal Decongestants Vasoconstrictor Agents Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013