To assess the safety, efficacy and subject satisfaction associated with volumization of the hip dell with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX).
The primary objectives of this clinical trial is to assess efficacy of adipose tissue generation (adipogenesis) and volumization following treatment of the hip dell with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX). Enrolled subjects will be randomized to two (2) treatment groups: "right hip dell treated" and "left hip dell treated". All subjects will receive three (3), single-sided injections of Sculptra® Aesthetic (Galderma Laboratories; Fort Worth, TX), performed one (1) month ± 7 days apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic saline, injected in the same manner as Sculptra® Aesthetic. One (1) vial of Sculptra® Aesthetic, diluted to 8mL, will be used per treatment session. Subjects satisfying all inclusion and no exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory digital photography with overhead lighting and VECTRA® (Canfield Scientific, Inc.; Parsippany, NJ) 3D volumetric body photography will be obtained of each subject's treatment area. In order to participate in the study, subjects must provide written informed consent to have their photographs used for research, publication, and/or commercial purposes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Injectable biostimulant for volume loss
Sham Comparator
West Dermatology Research Center/Cosmetic Laser Dermatology
San Diego, California, United States
Histological Analysis
Comparison of measure of adipose tissue in biopsies taken from device and sham treated areas prior to baseline and at followup visits
Time frame: Baseline to three months post final treatment
Histological Analysis
Comparison of measure of adipose tissue in biopsies taken from device and sham treated areas prior to baseline and at followup visits
Time frame: Baseline to six months post final treatment
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Pre-Treatment Visit 2/ Baseline
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Pre-Treatment Visit 3/ Day 14
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Pre-Treatment Visit 4/ Day 44
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Pre-Treatment Visit 5/ Day 74
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Visit 6/ Day 104
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
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Time frame: Visit 7/ Day 164
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Visit 9/ Day 254
Volumetric Analysis
Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography
Time frame: Visit 11/ Day 344
Physician Global Aesthetic Improvement Scale
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Time frame: 1 Month Follow-Up visit
Physician Global Aesthetic Improvement Scale
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Time frame: 3 Month Follow-Up visit
Physician Global Aesthetic Improvement Scale
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Time frame: 6 Month Follow-Up visit
Physician Global Aesthetic Improvement Scale
Blinded-Evaluator assessment of change in appearance of treated areas where 1 + Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, and 5 = Worse
Time frame: 9 Month Follow-Up visit
Identification of correct Treatment Area (Right vs Left Hip)
Blinded-Evaluator performed assessment of which side received study treatment and which received sham
Time frame: 9 Month Follow-Up visit
Collagen Analysis
Quantitative analysis of collagen amounts based on histology
Time frame: Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits
Elastin Analysis
Quantitative analysis of elastin amounts based on histology
Time frame: Upon analysis of biopsies collected at Day 0 and 3 and 6 Month Follow-Up visits
Skin Thickness
Ultrasound imaging measurements of skin thickness/thickness of dermis
Time frame: Day 0 and 3, 6, and 9 Month Follow-Up visits
Subject Global Aesthetic Improvement Score
Subject assessment of change in appearance of treated areas rated numerically from 1 to 5 with 1 being very much improved to 5 being worse
Time frame: 1, 3, 6, and 9 Month Follow-Up visits
Subject Satisfaction Questionairre
Degree of subject satisfaction with treatment outcomes rated numerically from 0 to 4 with 0 being not satisfied to 4 being extremely satisfied
Time frame: 1, 3, 6, and 9 Month Follow-Up visits
Evaluation of Side Effects
Assessment of treatment related adverse events by Investigator
Time frame: Day 44, Day 74, Day 104, Day 164, Day 178, Day 254, Day 268, Day 433