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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Subjects will receive PLLA injections to the right knee and bacteriostatic water to the left.
Subjects will receive PLLA injections to the left knee and bacteriostatic water to the right.
West Dermatology Research Center
San Diego, California, United States
Investigator Assessed Improvement
Blinded Investigator Grading
Time frame: Baseline to 6 Months post final treatment
Subject Assessed Improvement
Subject Global Aesthetic Improvement Scale (SGIAS)
Time frame: Baseline to 6 Months post final treatment
Subject Assessed Satisfaction
Subject Satisfaction Questionnaire
Time frame: Baseline to 6 Months post final treatment
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