Topical Timolol for Superficial Infantile Hemangioma
Status:
Unknown status
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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.