The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the injection technique.
Restylane Lip Volume is intended to be used for lip enhancement and Restylane Lip Refresh is intended to restore hydrobalance and improve skin structure of the lips (referred to as lip rejuvenation in this protocol), respectively. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this open, multicenter study are to evaluate efficacy and safety of the products for the studied indications and to collect information on injection techniques used.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
Göteborgs Plastikkirurgiska Center
Gothenburg, Sweden
Stureplanskliniken
Stockholm, Sweden
Akademikliniken
Stockholm, Sweden
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment
To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.
Time frame: At week 8 - change of lips from baseline
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment
To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.
Time frame: week 36 - change from baseline
GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment
To evaluate esthetic change of lips from baseline as judged by the treating investigator using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change.
Time frame: week 36 - change from baseline
GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment
To evaluate esthetic change of lips from baseline as judged by the independent evaluator using GEIS at week 2, 4, 12, 26 and 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.
Time frame: week 36 - change from baseline
MLFS (Medicis Lip Fullness Scale) at Week 8
To evaluate the efficacy in terms of Medicis Lip Fullness Scale (MLFS) score by live assessment performed separately by the treating and the independent investigators in the Restylane Lip Volume group. The scale has five levels: Very thin, thin, median, full, very full. Treatment success is defined as at least one grade increase.
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Time frame: week 8 - change from baseline
Subject Satisfaction Questionnaire
To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire at week 8 after treatment. The subject satisfaction questionnaire consists of questions regarding the looks, appearance, disomfort, and satisfaction regarding the treatment of the lips. The question that will be referred to is: How satisfied are you today with (the look of) your lips ?
Time frame: Week 8
Subject Diary for 14 Days After Initial Treatment
To evaluate the acute safety profile (bruising, itching, pain, redness, swelling and tenderness) in terms of a 14-day subject diary after initial treatment. Subjects still reporting one or more of the symptoms; bruising, itching, pain, redness, swelling and tenderness in the diary at day 14.
Time frame: 2 weeks after initial treatment