Publicidad
Idiomas disponibles
Idiomas disponibles
in the SkinPen Precision device, which may affect the device effectiveness results. Therefore,
the safety assessments collected for both treatment groups are included in the summary
below. However, for the effectiveness results, only the data for the SkinPen Precision group
was considered.
Subjects enrolled in the study included both men (31.7%) and women (68.3%) over the age of 21.
The study included 11/41 subjects with Fitzpatrick Skin Type (FST) V and VI.
Table 3: Summary of Demographic Information
N
Age (years)
Mean (standard deviation)
Minimum, Median, Maximum
Sex
Male
Female
Ethnicity
Hispanic or Latino
Not Hispanic or Latino
Race
American Indian or Alaska Native
Asian
Black or African American
White
Fitzpatrick Skin Type
II
III
IV
V
VI
At each clinical visit, digital images were taken of each subject's facial acne scars. On day 1, day
30, and day 60, imaging was performed prior to treatment. A total of 3 full-face images were
collected. Images were also collected at the 1 month and 6 month follow-up visit. These images
were graded by two separate Board Certified Dermatologists after completion of the study using
the following assessment tools and timepoints [Table 4]. Details of each of these assessment
tools are provided below in Tables 5-7. The results of the study are provided in Tables 8-12.
Jwala Karnik, Leslie Baumann, Suzanne Bruce, Valerie Callender, Steven Cohen, Pearl Grimes, John Joseph,
1
Ava Shamban, James Spencer, Ruth Tedaldi, William Philip Werschler, Stacy R. Smith, "A double-blind,
randomized, multicenter, controlled trial of suspended polymethylmethacrylate microspheres for the
correction of atrophic facial acne scars" Journal of the American Academy of Dermatology 71(1):77-83 (2014).
4
PN#P5SP012.01 | International
P5SP012.01_SPP_IFU_INTL_6Language_20200120.indd 4
P5SP012.01_SPP_IFU_INTL_6Language_20200120.indd 4
SkinPen Precision System
20
43.8 (12.7)
23, 48, 60
N
(%)
7
35
13
65
6
30
14
70
1
5
3
15
6
30
10
50
2
10
4
20
7
35
4
20
3
15
All Subjects
41
44 (11.9)
21, 46, 60
N
(%)
13
31.7
28
68.3
13
31.7
28
68.3
2
4.9
9
22.0
10
24.4
20
48.8
3
7.3
10
24.4
17
41.5
7
17.1
4
9.8
2/18/20 1:57 PM
2/18/20 1:57 PM
Publicidad
