Topical Timolol for Superficial Infantile Hemangioma

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Hemangioma

Treatments: Drug: 0.5% timolol maleate eye drop; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01685398

088/2555(EC4)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: Under 2 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

normal saline

Placebo Comparator group

Description:

normal saline 1-2 drops put on the hemangioma lesion 4 times a day and rub over the entire lesion with a finger

Treatment:

Drug: Normal saline

0.5% timolol maleate eye drop

Experimental group

Description:

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

Treatment:

Drug: 0.5% timolol maleate eye drop