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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.
1
Jwala Karnik, Leslie Baumann, Suzanne Bruce, Valerie Callender, Steven Cohen, Pearl Grimes, John Joseph,
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#16130014 | Rev. C | International
SkinPen Precision System
All Subjects
20
41
43.8 (12.7)
44 (11.9)
23, 48, 60
21, 46, 60
N
(%)
N
7
35
13
13
65
28
6
30
13
14
70
28
1
5
2
3
15
9
6
30
10
10
50
20
2
10
3
4
20
10
7
35
17
4
20
7
3
15
4
Table 4: Study Endpoints
Primary
effectiveness
endpoints
Secondary
effectiveness
endpoints
(%)
Safety
Endpoint
31.7
68.3
The photo grading included the following effectiveness assessments:
31.7
• Acne Scar Assessment Scale
68.3
Table 5: Acne Scar Assessment Scale
Grade Term
4.9
0
Clear
22.0
24.4
1
Very mild A single depression is easily noticeable with direct lighting (deep). Most
48.8
7.3
2
Mild
24.4
41.5
3
Moderate More than half of the depressions are apparent with direct lighting (deep).
17.1
4
Severe
9.8
In addition to the clinician graded effectiveness measures, the following patient-reported
measures were recorded throughout the study:
• Self-assessed Scar Improvement Scale
Table 6: Self-assessed Scar Improvement Scale
Rating
-1
0
1
2
3
4
Acne Scar Assessment Scale graded by two blinded dermatologists using
photographs taken at baseline, day 30, day 60, 1-month post-treatment, and
6-months post-treatment
Clinician's Global Aesthetic Improvement Assessment graded by two blinded
dermatologists using photographs taken at 1-month post-treatment, and
6-months post-treatment
Self-assessed Scar Improvement Scale completed by subjects at baseline,
1-month post-treatment, and 6-months post-treatment
Subject Global Aesthetic Improvement Scale completed by subjects at
baseline, 1-month post-treatment, and 6-months post-treatment
Patient Satisfaction Questionnaire completed by subjects at 1-month post-
treatment and 6-months post-treatment
Subject safety diaries provided to the subject at each treatment visit (day 1, 30,
and 60) and completed for 30 days to record treatment responses
Adverse event monitoring at each visit; baseline, day 30, day 60, 1-month post-
treatment, and 6-months post-treatment
1
Description
No depressions are seen in the treatment area. Macular discoloration may
be seen.
or all of the depressions seen are only readily apparent with tangential
lighting (shallow).
A few to several, but less than half of all the depressions are easily
noticeable with direct lighting (deep). Most of the depressions seen are
only readily apparent with tangential lighting (shallow).
All or almost all the lesions can be seen with direct lighting (deep).
Description
Exacerbation of Acne Scars
No change in appearance of acne scars
1% - 25% improvement in appearance of acne scars
25% - 50% improvement in appearance of acne scars
50% - 75% improvement in appearance of acne scars
75% - 99% improvement in appearance of acne scars
PN#16130014 | Rev. C | International
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