BioMed Research International / 2015 / Article / Tab 2

Clinical Study

An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds

Table 2

MFWS grades at each study time point.

DayNLFNumber (%)a of subjects with MFWS grade
00.511.522.53

Day 0
()
Right30 (62.5)16 (33.3)2 (4.2)
Left26 (54.2)19 (39.6)3 (6.3)

Day 14
()
Right 4 (8.3)18 (37.5)19 (39.6) 7 (14.6)
Left 6 (12.5)11 (22.9)24 (50.0) 7 (14.6)

Day 30
()b
Right 4 (8.5)18 (38.3)22 (46.8) 3 (6.4)
Left 5 (10.6)16 (34.0)24 (51.1) 2 (4.3)

Day 90
()b
Right 4 (8.5)15 (31.9)25 (53.2) 3 (6.4)
Left 4 (8.5)13 (27.7)27 (57.4) 3 (6.4)

Day 180
()b
Right 1 (2.1)14 (29.8)25 (53.2) 6 (12.8) 1 (2.1)
Left 1 (2.1)13 (27.7)26 (55.3) 5 (10.6) 2 (4.3)

Day 270
()b
Right14 (29.8)20 (42.6)12 (25.5)1 (2.1)
Left13 (27.7)23 (48.9)10 (21.3)1 (2.1)

Grade 0 = no wrinkle; Grade 0.5 = very shallow yet visible wrinkle; Grade 1 = fine wrinkle; Grade 1.5 = visible wrinkle and clear indentation; Grade 2 = moderate wrinkle; Grade 2.5 = prominent and visible wrinkle; Grade 3 = deep wrinkle
Percentages are based on the number of subjects with available data.
One subject was lost to follow-up after Day 14.
Safety analysis data set: SAF.
MFWS = Modified Fitzpatrick Wrinkle Scale, = number of subjects with available data, and NLF = nasolabial fold.

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