The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Skin and Laser Center
Boom, Belgium
Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale
Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome.
Time frame: 36 weeks
Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire
Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome.
Time frame: 36 weeks
Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)
Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear.
Time frame: 36 weeks
Assessment of Local Tolerability After Treatment
Number of subjects reporting anticipated injection-related reactions after treatment
Time frame: 14 days
Adverse Event Reporting During the Study
Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment)
Time frame: 36 weeks
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