Bellus Medical SkinPen Manual Del Usuario página 10

reporting no change. The mean value for the population was = 1.65 and 1.70, at 1-month
post-treatment and 6-months post-treatment respectively (1%-25% improvement in
appearance of acne scars) when compared with a score of 0 (no change in appearance of
acne scars). No subjects reported a negative score (i.e., exacerbation of acne scars) at either
post-treatment timepoint.
Subject Global Aesthetic Improvement Scale:
Treatment with SkinPen Precision produced an improvement in SGAIS scores at 1 month
post-treatment and 6 months post-treatment. At 1-month post-treatment, 7 (35%) subjects
reported much improved, 9 (45%) subjects reported improved, and 4 (20%) subjects reported
no change. At 6-months post-treatment, 2 (10%) subjects reported very much improved,
8 (40%) subjects reported much improved, 8 (40%) subjects reported improved, and 2
(10%) subjects reported no change. The mean value for the population was = 2.85 and 2.50,
at 1-month post-treatment and 6-months post-treatment respectively (improved) when
compared with a score of 4 (no change). No subjects reported a score of 5 (worse) at either
post treatment timepoint.
Patient Satisfaction Questionnaire:
The results of the patient satisfaction questionnaire for all subjects indicated that a greater
proportion of subjects selected favorable responses regarding treatments at 1 month and 6
months post-treatment for the following inquiries:
• Question 1: Do you notice any improvement in how your acne scars look in the treated area?
Table 10: Results of Patient Satisfaction Questionnaire - Question 1
Time Point
1-Month Post-Treatment
6-Months Post-Treatment
• Question 2: How would you characterize your satisfaction with the treatment?
Table 11: Results of Patient Satisfaction Questionnaire – Question 2
Time Extremely
Point Satisfied
[N (%)]
1-Month 3 (15.0)
Post-
Treatment
6-Months 3 (15.0)
Post-
Treatment
• Question 3: Would you recommend this treatment to your friends and family members?
Table 12: Results of Patient Satisfaction Questionnaire – Question 3
Time Point
1-Month Post-Treatment
6-Months Post-Treatment
For additional information refer to the SkinPen
8 PN#P5SP012.01 | International
P5SP012.01_SPP_IFU_INTL_6Language_20200120.indd 8 P5SP012.01_SPP_IFU_INTL_6Language_20200120.indd 8
Yes [N (%)]
16 (80.0)
18 (90.0)
Satisfied Slightly Neither
[N (%)] Satisfied Satisfied nor
[N (%)] Dissatisfied
[N (%)]
9 (45.0) 5 (25.0) 3 (15.0)
9 (45.0) 5 (25.0) 1 (5.0)
Yes [N (%)]
18 (90.0)
18 (90.0)
Precision User Manual PN#P5SP013.01
®
No [N, (%)]
4 (20.0)
2 (10.0)
Slightly Dissatisfied
Dissatisfied [N (%)]
[N (%)]
0 (0.0) 0 (0.0)
1 (5.0) 1 (5.0)
No [N, (%)]
2 (10.0)
2 (10.0)
Very
Dissatisfied
[N (%)]
0 (0.0)
0 (0.0)
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