The purpose of the study is to evaluate the safety and efficacy of Restylane Vital White administered with an injector device on aged skin in the face, hands and décolletage.
The objectives are to explore the safety and efficacy profile of Restylane Vital White administered with an injector device when one side of the face, one of the hands and one side of the décolletage is treated and the other side of the face, the other hand and the other side of the décolletage is left untreated. The face, the hands and the décolletage will be evaluated separately for both the efficacy and the safety parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Treatment of up to 4 ml for one side of the face, one hand and one side of the décolletage dispensed by 10ul doses 0.5-1 cm apart. 3 treatment sessions 4 weeks apart.
One side of face, one hand and one side of the décolletage is left untreated as a control.
University of Hamburg
Hamburg, Germany
Elasticity
To evaluate the change in elasticity from baseline for the treated and untreated side respectively.
Time frame: 0,4,8,12,20,28,36 weeks
GEIS subject
To evaluate esthetic change from baseline as judged by the subjects using GEIS for the treated and untreated side respectively
Time frame: 4,8,12,20,28,36 weeks
GEIS blinded evaluator
To evaluate esthetic change from baseline as judged by the blinded evaluator using GEIS for the treated and untreated side respectively,
Time frame: 12,20,28,36 weeks
Skin structure
To evaluate the change in skin structure from baseline for the treated and untreated side respectively.
Time frame: 0,4,8,12,20,28,36 weeks
Subject satisfaction
To evaluate subject satisfaction
Time frame: 0,12,20,28,36 weeks
Best skin quality by blinded live evaluation
To evaluate best skin quality of treated and untreated side judged by a blinded live evaluation
Time frame: 12,20,28,36 weeks
Adverse Events
To evaluate the safety of Restylane Vital White during the whole study by collecting Adverse Events
Time frame: 0-36 weeks
Subject diary
To evaluate the acute safety profile, i.e. treatment procedure reactions by direct questioning to subjects in a diary used daily for 2 weeks after each injection.
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Time frame: 2 weeks after each treatment