Topical Timolol for Superficial Infantile Hemangioma

NCT ID: NCT01685398

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2023-03-31

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.

Conditions

Hemangioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

0.5% timolol maleate eye drop

Intervention Type: DRUG

Interventions

0.5% timolol maleate eye drop

Intervention Type: DRUG

Normal saline

Intervention Type: DRUG

Other Intervention Names

Saline

Eligibility 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

• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, Thailand

Countries

Thailand

Other Identifiers

088/2555(EC4)

Identifier Type: -

Identifier Source: org_study_id