Topical Timolol for Superficial Infantile Hemangioma

Hemangioma Clinical Trial

Official title:

Treatment of Cutaneous Hemangioma of Infancy With Topical 0.5% Timolol Maleate Eye Drop Compared With Placebo in Pediatric Patients, Siriraj Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685398
• Other study ID #: 088/2555(EC4)
• Status: Completed
• Phase: Phase 3
• Start date: September 2012
• Est. completion date: March 2023

Study information

• Verified date: September 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma

Intervention

Drug:
• 0.5% timolol maleate eye drop

• Normal saline

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo	Percent changes in visual analogue scale of the lesion color and global assessment scale of the lesion after treatment	6 months
Secondary	Side effects of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma	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.	6 months