Diagnosis and Management of Infantile Hemangioma

Table 25. Key resolution outcomes in studies comparing PDL and observation
Author, Year
Groups (n)
Quality
Age, Months
Type
Location
Methods and Measures
of Resolution/
Response
Resolution Outcomes
Kessels et al.
2013 210
G1: Pulsed dye
laser (11)
G2:
Observation
(11)
Quality: Good
Batta et al.
2002 212
G1: Pulsed dye
laser (60)
G2:
Observation
(61)
Quality: Fair
Age, median
(range)
G1: 3 (1.7-5.0)
G2: 3 (1.5-4.5)
Type
Superficial and
cutaneous only
Age, median
(range, days
G1: 38 (10 to
101)
G2: 32 (5 to
79)
Type, n (%)
Flat
G1: 31 (52)
G2: 30 (49)
Raised
G1: 29 (48)
G2: 31 (51)
G1+G2:
multiple
G1+G2:
multiple
G = group; n = number; PDL = pulsed dye laser
• Photographs
• Color measured by
reflectance
photometer
• Improvement scale
evaluated by blinded
panel
1= no improvement
2= moderate
improvement
3 = significant
improvement
• Photographs
• Primary outcome
measure assessed by
investigator: complete
clearance or
minimum residual
signs at age 1 year
• Blinded medical
observer assessed
redness (secondary
outcome measure)
Change in echo depth, median
(interquartile range)
G1: -1.21 (-1.75 to 0.15)
G2: -1.10 (-2.00 to 0.96)
G1 vs.G2 p= 0.69
Change in surface, median
(interquartile range)
G1: 0.40 (0.10 to 0.80)
G2: 0.00 (-0.08 to 0.40)
G1 vs.G2 p= 0.08
Color change, median
(interquartile range)
G1: 10.16 (5.50 to 15.41)
G2: 4.23 (0.84 to 5.28)
G1 vs.G2 p= 0.03
Complete clearance or minimum
residual signs, n (%)
G1: 25 (42)
G2: 27 (44)
G1 vs.G2: p=0.92
Complete only
G1: 18 (30)
G2: 3 (5)
G1 vs.G2: p=0.001
Comparative Effectiveness of Various PDL Modalities
One fair quality Japanese RCT 211 randomized 52 patients to a “traditional PDL” group and a
“long-pulse” dye laser group (pulse durations of 0.45 milliseconds vs. 10-20 milliseconds). The
percentage of patients achieving an excellent (76-100%) clearance of the lesion did not differ
between groups, with rates of 54 to 65 percent in each group. Time to maximal proliferation was
significantly shorter (106 days) in the longer pulse PDL group compared with the traditional
PDL group (177 days, p=0.01). Another fair quality cohort study comparing short and longer
pulse PDL similarly reported no significant differences in the number of children with complete
or near-complete resolution by age 3 to 3.5 years. 213
In a poor quality cohort study evaluating cryogen spray cooling as an adjunct to PDL versus
no cooling in 164 children (mean age overall= 2 years, 11 months), c 216 hildren in the cryogen
cooling arm required fewer treatments and had greater improvements in volume and texture than
children in the non-cooled PDL arm (p values