Bellus Medical SkinPen Manual Del Usuario página 8

• Subject Global Aesthetic Improvement Scale
Table 7: Subject Global Aesthetic Improvement Scale
Rating Description
1 Very Much Improved: Optimal cosmetic result.
Much Improved: Marked improvement in appearance from the initial condition,
2
but not completely optimal.
3 Improved: Obvious improvement in appearance from initial condition.
No Change: The appearance is essentially the same as the original condition.
4
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
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