Comparision of efficacy of combination PDL laser with topical propranolol and PDL laser alone in treatment of infantile hemangioma.

A ranomised single blinded without placebo control uni-central study.Patients involved with infantile hemangioma who are visited in dermatology clinic of Razi Hospital who are meeting Inclusion and Exclusion crateria are involved in this study. Inclusion crateria : 1-Hemangioma located in non-sensitive area(include nose-ear-eyelid-lips) 2-Patient compliance with study 3-No previous treatment(with systemic corticosteroids or other drugs) received in the last 3 months. 4-Patients shold not have any systemic involvement(congenital heart disease-renal disease) 5-Hemangioma in the proliferative phase of evolution(age<2 years). Exclusion crateria: 1-no response after 4 weeks of treatment 2-Allergic reaction to anyone of topical drugs. 3-Side effects of topical propranolol (e.g erythema,pruritus,inflamation......) Patient who meet inclusion criteria are randomized to two groups A, B . Table of random numbers will be helpful to divide patients. Group A of patients treated with PDL every 4 weeks while patients in group B in addition to the PDL laser every 4 weeks will receive topical ointment propranolol daily as a thin layer to cover the entire lesion up to 3 months. PDL with the following laser parameters will be done for all patients: Spot Size: 7mm, Fluence: 12J/Cm2, Duration 1.5ms, DCD = 40/40. Before treatment of all lesions will be taken a phtograph with a view Close-up digital photo camera. After 4 , 8,12 and 16 weeks of treatment patients are followed. Reduction in lesion size by comparing images taken before and after treatment of lesions based on the VAS (Visual Analogue Scale) will be performed. Accordingly, less than 25% reduction in lesion size is equivalent to 1 score- between 25% to 50% reduction in size is equivalent to 2 scores, reduction between 50% to 75% of size is equivalent to 3 and finally more than 75% reduction in size is equivalent 4 score. Comparison of images before and after treatment by two dermatologists who have not participated in the study will be performed and an estimation of average of both scores will be the final result of size reduction.The T-test will be used to compare results and to determine significant differences .

Tehran University Of Medical Sciences