Bellus Medical SkinPen Precision Mode D'emploi page 5

• Subject Global Aesthetic Improvement Scale
Table 7: Subject Global Aesthetic Improvement Scale
Rating Description
1 Very Much Improved: Optimal cosmetic result.
2 Much Improved: Marked improvement in appearance from the initial condition,
but not completely optimal.
3 Improved: Obvious improvement in appearance from initial condition.
4 No Change: The appearance is essentially the same as the original condition.
5 Worse: The appearance is worse than the original condition.
• Patient Satisfaction Questionnaire
Three questions were asked to the subjects in the study regarding their level of satisfaction
with the treatment. It was included as a secondary endpoint in the study. See individual
questions and results in the section below.
Safety information was collected throughout the study using subject safety diaries. Safety
diaries were provided to the subject at each treatment visit (day 1, 30, and 60). The subject
was instructed to record any observations related to treatment including common treatment
responses. Common treatment responses are side effects that result from treatment which
resolve on the order of days. Common treatment responses that persist may be categorized
as adverse events when assessed by the investigator at the next visit.
Subjects were informed of the following potential common treatment responses in the
informed consent process: skin will be red and flushed similar to a moderate sunburn, skin
tightness and mild sensitivity to the touch, redness, burning, tingling, stinging, itching, and/
or scaling/dryness, edema (swelling), tenderness/discomfort, a possibility of developing an
infection (an increase in redness, warmth, itching, or pus formation). The diaries included
space for daily recording of observations for the 30 days in between treatment visits. Adverse
events were assessed by the investigator at each subsequent visit.
Results:
Safety:
At the 6-month post-treatment visit, no adverse events persisted.
The following common treatment responses were reported in the subject safety diaries which
were sent home with the subject:
• Dryness in 5/41 (12%) subjects lasting from 1-6 days
o These responses were reported by 3 subjects with FST III, 1 subject with FST VI, and 1
subject with FST V
• Rough Skin in 3/41 (7%) of subjects lasting from 1-2 days
o These responses were reported by 1 subject with FST III, and 2 subjects with FST V
• Tightness in 2/41 (4%) of subjects lasting from 1-2 days
o These responses were reported by 2 subjects with FST VI
• Redness, Itching, Peeling Discomfort and Tenderness in 13/41 (31%) of subjects lasting 1-3 days
o These responses were reported by 6 subjects with FST III, 2 subjects with FST VI, 3 subjects
with FST V, and 2 subjects with FST V
• Burning in 4/41 (9%) of subjects lasting 1-3 days
o These responses were reported by 1 subject with FST III, 1 subject with FST VI, and 2
subjects with FST V
6 PN#16130014 | Rev. C | International
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 N Mean Standard Deviation Minimum Median Maximum
Baseline 20 2.80
Day 30 20 2.78
Day 60 20 2.70
1-Month Post-Treatment 20 2.68
6-Months Post-Treatment 20 2.35
Table 9: Change from Baseline for Photo Grading of Acne Scar Assessment Scale for
SkinPen Precision System
Time Point N Subject
Improved
(%)
Day 30 20 30.0
Day 60 20 35.0
1-Month Post-Treatment 20 40.0
6-Months Post-Treatment 20 55.0
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
0.52 2.00 3.00 4.00
0.57 2.00 2.75 4.00
0.55 2.00 2.50 3.50
0.49 2.00 2.50 3.50
0.69 1.50 2.50 3.50
Subject Mean Standard Mean
Worsened Change Deviation for Change
(%) Change (%)
20.0 -0.03 0.50 -0.9
20.0 -0.10 0.50 -3.6
20.0 -0.13 0.58 -4.5
0.0 -0.45 0.46 -16.1
PN#16130014 | Rev. C | International 7