Introduction
Originally described by Mulliken and Glowacki1,
infantile haemangioma (IH) is the most common benign tumour in
children2,3. IH belongs to the group of vascular
tumours in the ISSVA (international society for the study of vascular
anomalies) classification4. Usually, IH will appear at
birth or within the first few weeks after birth, and up to 3 months of
age for subcutaneous haemangioma5. IH is characterized
by its natural course divided into three phases, a proliferative phase
characterized by a rapid growth of the tumour (up to 6 to 12 months of
life), a stabilization phase (from 12 to 36 months of life), and an
involution phase marked by the regression of the
lesion6. This regression is complete in 90% of cases
by the age of 4, but without treatment we can observe up to 70%
residual lesions, such as fibrofatty tissue, telangiectasia, skin laxity
and scars7. The proliferative phase may be marked by
severe complications, such as necrosis, ulceration, bleeding or
infection. Obstruction and functional impairment such as amblyopia,
upper respiratory obstruction, obstruction of the nostrils or auditory
channel, sphincter dysfunction, or feeding disorders can be caused by
periorificial locations of IH (e.g. perioral and periorbital skin).
Moreover, the aesthetic impact is not trivial, especially when IHs
located in the centrofacial area are a source of disfigurement8,9. Large segmental facial IHs may be part of the
PHACES syndrome (posterior fossa anomalies, haemangioma, arterial
lesions, cardiac abnormalities, eye anomalies, sternal
defects)10,11 and segmental IHs of the lower body may
be part of the LUMBAR syndrome (lower body haemangioma, urogenital,
myelopathy, bony, anorectal and arterial, renal
anomalies)12. Finally, liver haemangioma and
haemangiomatosis are high-risk complicated IHs as they may lead to
cardiac failure13.
Initially, medical treatment of severe IH was based on systemic
corticosteroid therapy14,15. In 2008, Leaute-Labreze
et al. fortuitously discovered the anti-proliferative effect of
propranolol, when using this non-selective beta-blocker for a
hypertrophic obstructive cardiomyopathy, in a child with a nasal IH
treated by corticosteroids16. The efficacy of oral
propranolol in IH was demonstrated by two randomized controlled
trials17,18. In 2014 Pierre Fabre dermo-cosmetics
laboratory (Paris, France) obtained EMA (European Medicines Agency) and
FDA (Food and Drug Administration) marketing authorization for
Hemangiol®, the first and only drug currently approved for the treatment
of proliferating IH. Hemangiol® is indicated to treat IH in children
aged 5 weeks to 5 months, in case of life or functional risk, painful
ulcerated lesions, or risk of permanent scarring or facial damage.
In this paediatric post-marketing surveillance drug study, we aimed to
report the use of Hemangiol® in our institution from 2014 to 2018.