Knee Clinical Trial
Official title:
A Randomized, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Upper Knee Skin Laxity
All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.
Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left
side treated". All subjects will receive three, single-sided injections of PLLA, performed 1
month apart. Treatments will be provided to one randomly assigned knee. The non-treatment
knee will receive bacteriostatic water, injected in the same manner as PLLA. Up to one (1)
syringe of PLLA, diluted at 16 mL, will be used per session.
Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial.
Prior to receiving any study treatment, mandatory photography using 2D photography and Vectra
will be obtained of each subject's treatment area. All photographs may be used for research
and/or commercial use.
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