Diagnosis and Management of Infantile Hemangioma

placebo group (p values ≤ 0.07). Of the 19 patients treated with propranolol, two responded only
minimally (start of treatment at ages 5.5 and 11 months).
In one fair quality cohort study conducted in India, thirty-three children up to 10 years of age
with IH requiring treatment due to airway obstruction, ocular occlusion or compression, aesthetic
disfigurement or ulceration, who may have failed other treatment modalities, and those patients
greater than 12 months of age with continuous proliferation of their IH without signs of
resolution were treated with propranolol at a dose of 2 mg/kg/day divided twice daily. 94 The
study compared these participants with historical controls who had not previously received
therapy. Significant involution defined as a score of 5 to 9 on a 10-point scale (10=no change in
original IH, 0=normal skin) was seen in 28/31 (90.3%). All children 6 months of age and
younger responded (20/20, 100%). No child greater than 36 months of age (0/2, 0%) responded
to propranolol. Sixty-five to 80 percent of involution occurred in the first 8 weeks of propranolol
therapy. The overall mean involution score for the propranolol group compared with the control
group was 4.37 versus 8.38 (p< 0.0001). Table 10 outlines resolution outcomes in these studies.
Table 10. Key resolution outcomes in RCTs comparing propranolol and placebo or observation
Author, Year
Comparison
Groups (n)
Quality
Leaute-Labreze
et al. 2015 92
G1: Propranolol,
oral 3mg/kg/day
for 6 months
(102)
G2: Propranolol,
oral 3mg/kg/day
for 3 months
(101)
G3: Propranolol,
oral 1mg/kg/day
for 6 months
(103)
G4: Propranolol,
oral 1mg/kg/day
for 3 months
(99)
G5: placebo
(55)
Quality: Good
Age
Type
Age, days
mean±SD
G1: 101.6 ±
31.0
G2: 107.5 ±
30.1
G3: 102.6 ±
30.1
G4: 103.6 ±
33.1
G5: 103.9 ±
31.1
Type, n (%)
Segmental
G1: 5 (5)
G2: 7 (7)
G3: 7 (7)
G4: 4 (4)
G5: 2 (4)
Localized
G1: 91 (90)
G2: 88 (88)
G3: 90 (88)
G4: 89 (91)
G5: 48 (87)
Indeterminate
G1: 5 (5)
G2: 5 (5)
G3: 5 (5)
G4: 5 (5)
G5: 5 (9)
Location
G1+G2+G
3+G4+G5:
Multiple
Methods and
Measures of
Resolution/
Response
• Serial
photographs
and clinical
assessment by
blinded
investigators
• Nearly
complete
resolution
defined as
minimal
degree of
telangiectasis,
erythema, skin
thickening,
soft-tissue
swelling, and
distortion of
anatomic
landmarks
Resolution
Outcomes
Complete or
nearly
complete
resolution at
24 weeks, n
(%)
G1: 61/101
(60%)
G5: 2/25 (4%)
p< 0.0001
Rebound Growth/
Recurrence, n (%)
Other Outcomes
Need for additional
treatment
• 6 (10%) assigned to
propranolol required
systemic treatment
from week 24 to week
96
• 7 (11%) required any
additional hemangioma
treatment
39