Topical Timolol for Superficial Infantile Hemangioma

NCT01685398 | Completed Phase 3

• 1 other identifier: 088/2555(EC4)
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Side effects of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma

  6 months

Study Arms (2)

normal saline

PLACEBO COMPARATOR

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

0.5% timolol maleate eye drop

EXPERIMENTAL

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

Interventions

0.5% timolol maleate eye drop DRUG

0.5% timolol maleate eye drop

Normal saline DRUG

Also known as: Saline

normal saline

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Hemangioma

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 14, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)