A randomised, multi-centre, parallel-group efficacy and safety study evaluating two and three initial treatment sessions of Restylane Skinboosters Vital Lidocaine in the face.
Approximately 50 female subjects shall be treated with two or three initial treatment sessions including long-term follow-up 18 months after the initial treatment regimen. Efficacy and safety to be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Rosenpark Research
Darmstadt, Germany
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
Subject assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved.
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
Investigator assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved.
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months
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