Clinical Evaluation Of The Topical Timolol Efficacy And Safety In The Treatment Of Infantile Hemangioma

Abstract

Background: Infantile hemangiomas are the most common childhood soft tissue tumors. More than 50% of them occur in the head and neck region. As spontaneous regression occurs over years, active intervention is needed only for large complicated hemangiomas. But, even small uncomplicated hemangiomas in visibly prominent area like face can be emotionally disturbing to parents. Even after reassurance of spontaneous regression, often parents are not ready to wait for years to see the beautiful smile on their child's face.

Objectives: To evaluate the effectiveness and safety of topical timolol in Iraqi infants with hemangioma.

Patients & Methods: This prospective and clinical therapeutic study was conducted in Al-Kindy Teaching Hospitalin Baghdad – Iraq during the period between the beginning of September-2018 to the end of the October - 2019. A total of 28 infants with infantile hemangiomas were included in this study. They were treated with topical timolol maleate 0.5% ophthalmic solution applied at a dose of 1 drop for each 1 cm2 surface area of the lesion under occlusion by simple wound plaster twice daily before feeding for 16 weeks period of therapy. Changes in the length, width, thickness and color of the hemangiomas were recorded at regular interval. The response to treatment was evaluated by periodic clinical examination of hemangioma at 4th week, 8th week and at the end of 16th week of treatment. The results were interpreted by two methods; overall response rate in which the color, the size and the thickness were measured serially to identify the growth, and visual analogue scale in which two independent dermatologists were asked for their opinion about the response to treatment which was expressed in term of three classes; class 1, ineffective, class 2, controlled growth and class 3, promoted regression. The regression rate was percentage of patients with class 3, while efficacy rate was the sum percentage of patients with class 2 and class 3.

Results: This study showed thattopical timolol induced reduction in length, width, thickness and color in all treated 28 patients by the end of 16 weeks treatment course. By visual analogue scale, the treatment showed 85.7% regression rate and 96.4% efficacy rate for the same above mentioned treatment course. Complete ulcer healing of the 4 patients with ulcerated hemangiomas documented in the study was noticed without the need for use of other topical treatment for the ulcers. No major side effects were reported in treated children .None of the treated hemangioma was recurrent after cessation of treatment for a follow up period of 4 months.

Conclusion: Topical timololmaleate 0.5% solution is found to be an effective and safe treatment of infantile hemangiomasand, adding the fact that patients in this study did not receive any previous treatment for their hemangiomas, can be considered as a safe and effective first line therapy for cutaneous infantile hemangiomas.