Bellus Medical SkinPen Manual Del Usuario página 7

Table 4: Study Endpoints
Primary
effectiveness
endpoints
Secondary
effectiveness
endpoints
Safety
Endpoint
The photo grading included the following effectiveness assessments:
• Acne Scar Assessment Scale
Table 5: Acne Scar Assessment Scale
Grade Term
0 Clear
1 Very mild A single depression is easily noticeable with direct lighting (deep). Most
2 Mild
3 Moderate More than half of the depressions are apparent with direct lighting (deep).
4 Severe
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 Description
-1 Exacerbation of Acne Scars
0 No change in appearance of acne scars
1 1% - 25% improvement in appearance of acne scars
2 25% - 50% improvement in appearance of acne scars
3 50% - 75% improvement in appearance of acne scars
4 75% - 99% improvement in appearance of acne scars
P5SP012.01_SPP_IFU_INTL_6Language_20200120.indd 5 P5SP012.01_SPP_IFU_INTL_6Language_20200120.indd 5
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).
PN#P5SP012.01 | International 5
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