Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma

Summary

Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most frequent benign neoplasm. Treatment of IHs is indicated for approximately 10 to 20% of the cases. Two groups can be defined amongst indications for treatment: patients with absolute indication for treatment and patients with relative indication for treatment. Absolute or emergency indications comprise function or life threatening situations such as obstruction of airways, obstruction of vision, congestive heart failure, hepatic and coagulation problems. The following are considered relative indications: cases of large and disfiguring facial hemangiomas; locations that can result in a deformity and/ or permanent scar (nose, ear, lip, glabellar area); extensive face hemangiomas, mainly when there is dermal damage (more probable to scar); local complications such as ulceration, infection and bleeding as well as small hemangiomas in exposed areas (hands and face), mainly if pedunculated due to its ease of excision2,7. Treatment modalities vary according to the extension, location, presence of complications and the evolutional phase. A combination of various treatments is possible. Beta blockers are being used in children for approximately 40 years, with proven clinical safety and no cases of death or cardiovascular disease resulting from its direct use. Recently it was reported the use of beta blockers (propanolol) for IH treatment, with significant reduction of tumor volume after introduction of the beta blocker, in a short period of time, with stable results after the end of treatment, which suggested evidences of the benefits of this drug in the tumor treatment The proposal of this study is to assess the use of propanolol in IH treatment, quantifying its effectiveness and safety under continuous monitoring and comparing it to the use of oral corticosteroid. The investigators propose the assessment of the betablockers' use in comparison to the use of corticosteroids in infants with IH in the proliferative or involuting phases, with indication for clinical treatment, and that are not alarming nor urgent; in other words, the current relative indications for treatment.

Timeline

Start

2010-01

Primary completion

2014-12

Completion

2014-12

Publications

• Background Lawley LP, Siegfried E, Todd JL. Propranolol treatment for hemangioma of infancy: risks and recommendations. Pediatr Dermatol. 2009 Sep-Oct;26(5):610-4. doi: 10.1111/j.1525-1470.2009.00975.x.
• Background Frieden IJ, Drolet BA. Propranolol for infantile hemangiomas: promise, peril, pathogenesis. Pediatr Dermatol. 2009 Sep-Oct;26(5):642-4. doi: 10.1111/j.1525-1470.2009.00977.x. No abstract available.
• Background Maturo S, Hartnick C. Initial experience using propranolol as the sole treatment for infantile airway hemangiomas. Int J Pediatr Otorhinolaryngol. 2010 Mar;74(3):323-5. doi: 10.1016/j.ijporl.2009.12.008. Epub 2010 Jan 13.
• Background Buckmiller LM. Propranolol treatment for infantile hemangiomas. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):458-9. doi: 10.1097/MOO.0b013e328332a4eb.
• Background Mousa W, Kues K, Haas E, Lauerer P, Pavlakovic H, Schon MP, Zutt M. Successful treatment of a large hemangioma with propranolol. J Dtsch Dermatol Ges. 2010 Mar;8(3):184-6. doi: 10.1111/j.1610-0387.2009.07266.x. Epub 2009 Sep 25. English, German.
• Background Perez RS, Mora PC, Rodriguez JD, Sanchez FR, de Torres Jde L. [Treatment of infantile hemangioma with propranolol]. An Pediatr (Barc). 2010 Feb;72(2):152-4. doi: 10.1016/j.anpedi.2009.05.019. Epub 2009 Jul 23. No abstract available. Spanish.
• Background Denoyelle F, Leboulanger N, Enjolras O, Harris R, Roger G, Garabedian EN. Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. Int J Pediatr Otorhinolaryngol. 2009 Aug;73(8):1168-72. doi: 10.1016/j.ijporl.2009.04.025. Epub 2009 May 29.
• Background Michel JL, Patural H. [Response to oral propranolol therapy for ulcerated hemangiomas in infancy]. Arch Pediatr. 2009 Dec;16(12):1565-8. doi: 10.1016/j.arcped.2009.09.008. Epub 2009 Nov 4. French.
• Background Siegfried EC, Keenan WJ, Al-Jureidini S. More on propranolol for hemangiomas of infancy. N Engl J Med. 2008 Dec 25;359(26):2846; author reply 2846-7. doi: 10.1056/NEJMc086443. No abstract available.
• Background Leaute-Labreze C, Taieb A. [Efficacy of beta-blockers in infantile capillary haemangiomas: the physiopathological significance and therapeutic consequences]. Ann Dermatol Venereol. 2008 Dec;135(12):860-2. doi: 10.1016/j.annder.2008.10.006. Epub 2008 Nov 20. No abstract available. French.
• Background Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available.

Drugs

Indications