Bellus Medical SkinPen Manual Del Usuario página 9

Over the course of the study, 1 subject reported an arthropod bite on the inner right thigh
that was determined to be moderate and unlikely related to SkinPen prototype device.
1 subject (1/41, 2.4%) experienced an AE (skin striae [linear marks, ridges, or grooves] on the
forehead and both sides of the face) that was determined to be mild and possibly related to use
of the SkinPen Precision System. This AE was thought to be due to subject exposure to excess
sunlight soon after treatment which was against study instructions, yet resolved without any
additional complications.
Effectiveness:
Acne Scar Assessment Scale:
Results of photo grading using the Acne Scar Assessment Scale demonstrated that at baseline
the mean population score was mild at 2.80. Following the three treatments and 6 months of
follow-up, the mean population score was reported as mild at 2.35.
The evaluation by the blinded assessors indicated that seven subjects (7/20, 35%) had a
1-grade reduction in the Acne Scar Assessment Scale at 6-months post-treatment compared
to baseline. The seven subjects reporting a 1-grade reduction included 1 subject with FST II, 2
subjects with FST III, 1 subject with FST IV, 2 subjects with FST V, and 1 subject with FST VI.
In addition, 4 subjects (20%) showed an improvement greater than 0 but less than 1 on the
Acne Scar Assessment Scale, giving a total of 55% (11/20) of subjects showing improvement
at 6-months post-treatment when compared with baseline. At 6-months post-treatment,
the remaining 9 subjects (45%) reported no change in score when compared to baseline.
The visual improvements seen in the photo grading results were considered to be
clinically meaningful.
Table 8: Results of Photo Grading of Acne Scar Assessment Scale for SkinPen
Precision System
Time Point
Baseline
Day 30
Day 60
1-Month Post-Treatment
6-Months Post-Treatment 20
Table 9: Change from Baseline for Photo Grading of Acne Scar Assessment Scale for
SkinPen Precision System
Time Point
Day 30
Day 60
1-Month Post-Treatment
6-Months Post-Treatment
Self-assessed Scar Improvement Scale:
Treatment with SkinPen Precision produced an improvement in SASIS scores at 1 month
post-treatment and 6-months post-treatment. At 1-month post-treatment, 17 (85%) subjects
reported some percentage of improvement in the appearance of their acne scars, with 3
(15%) subjects reporting no change. At 6-months post-treatment, 18 (90%) subjects reported
some percentage of improvement in the appearance of their acne scars, with 2 (10%) subjects
P5SP012.01_SPP_IFU_INTL_6Language_20200120.indd 7 P5SP012.01_SPP_IFU_INTL_6Language_20200120.indd 7
N Mean Standard Deviation Minimum Median Maximum
20 2.80 0.52
20 2.78 0.57
20 2.70 0.55
20 2.68 0.49
2.35 0.69
N Subject Subject
Improved Worsened
(%) (%)
20 30.0 20.0
20 35.0 20.0
20 40.0 20.0
20 55.0 0.0
2.00 3.00
2.00 2.75
2.00 2.50
2.00 2.50
1.50 2.50
Mean Standard
Change Deviation for
Change
-0.03 0.50
-0.10 0.50
-0.13 0.58
-0.45 0.46
PN#P5SP012.01 | International
4.00
4.00
3.50
3.50
3.50
Mean
Change
(%)
-0.9
-3.6
-4.5
-16.1
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