Diagnosis and Management of Infantile Hemangioma

Table 18. Resolution outcomes in studies comparing forms of propranolol
Author,
Year
Comparison
Groups (n)
Quality
Zaher et al.
2013 93
G1:
Propranolol
oral,
2mg/kg/day
in 2 daily
doses (15)
G2:
Propranolol,
topical, 1%
ointment
applied twice
daily (15)
G3:
Propranolol,
intralesional,
1mg injected
weekly (15)
Quality: Fair
Age,
Months
Type
Age,
mean±SD
(range)
G1+G2+G
3:
8.82±4.6
(3-18)
G1: 9.13
(3-18)
G2: 8.33
(1-18)
G3: 9.0 (3-
18)
Type
NR
Location
G1+G2+
G3:
multiple
Methods and
Measures of
Resolution/Response
• Grading system
comparing
photographic
documentation;
unblinded
assessment
• Excellent: complete
resolution achieved
• Good: sustained
plateau with ≥ 50%
reduction in size
• Fair: sustained
plateau with < 50%
reduction in size
• Poor: no response
or worsening of IH
Resolution
Outcomes
Response to
treatment, n (%)
Excellent response
G1: 9 (60)
G2: 3 (20)
G3: 2 (13.3)
Good response
G1: 2 (13.3)
G2: 5 (33.3)
G3: 3 (20)
Fair
G1: 1 (6.7)
G2: 2 (13.3)
G3: 3 (20)
Poor
G1: 3 (20)
G2: 5 (33.3)
G3: 7 (46.7)
Rebound
Growth/Recurrence,
n (%)
Rebound growth, n
(%)
G1: 1 (6.7)
G2: 1 (6.7)
G3: 2 (13.3)
G = group; IH = infantile hemangioma; kg = kilogram; mg = milligram; n= number; NR = not reported; SD = standard deviation
Timolol Versus Placebo/Observation or Other Modalities
Timolol Compared With Placebo or Observation
In a good quality double-blind, placebo-controlled RCT conducted in Australia, investigators
randomly assigned 41 infants ages 5 to 24 weeks with small, focal, superficial IH not requiring
systemic therapy to treatment with placebo (n=22) or timolol maleate 0.5 percent gel (n=19). 104
Investigators reported a significant increase in the number of IH lesions decreasing in size by
≥5 percent in the timolol group compared with the placebo group at weeks 8 (37% vs. 5%, p=
0.04), 20 (47% vs.6%, p= 0.02), and 24 (60% vs.11%, p= 0.01). At 24 weeks, 47 percent of the
timolol treated group had significantly increased difference in blinded photo score of 0 (no
redness) compared with 6 percent in the placebo group, while the proportion of lesions
completely red in the treatment group (6%) was significantly less than the placebo group (55%, p
values