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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| injectable poly-L-lactic acid | Experimental | One side of the subject's hips will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX). |
|
| Normal Saline | Sham Comparator | One side of the subject's hips will be treated with injectable normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injectable poly-L-lactic acid | Device | Injectable biostimulant for volume loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological Analysis | Comparison of measure of adipose tissue in biopsies taken from device and sham treated areas prior to baseline and at followup visits | 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 | Baseline to six months post final treatment |
| Volumetric Analysis | Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography | Pre-Treatment Visit 2/ Baseline |
| Volumetric Analysis | Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography | Pre-Treatment Visit 3/ Day 14 |
| Volumetric Analysis | Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography | Pre-Treatment Visit 4/ Day 44 |
| Volumetric Analysis | Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography | Pre-Treatment Visit 5/ Day 74 |
| Volumetric Analysis | Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography | Visit 6/ Day 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Collagen Analysis | Quantitative analysis of collagen amounts based on histology | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects must self-report as female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center/Cosmetic Laser Dermatology | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.
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Subject and Outcome Assessor will be unaware of which side of the subject is treated with the study device and which is treated with saline.
| Normal Saline | Other | Sham Comparator |
|
| Volumetric Analysis | Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography | Visit 7/ Day 164 |
| Volumetric Analysis | Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography | Visit 9/ Day 254 |
| Volumetric Analysis | Analysis of tissue volume in treatment zones based on measurements obtained via 3D photography | 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 | 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 | 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 | 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 | 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 | 9 Month Follow-Up visit |
| 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 | 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 | 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 | 1, 3, 6, and 9 Month Follow-Up visits |
| Evaluation of Side Effects | Assessment of treatment related adverse events by Investigator | Day 44, Day 74, Day 104, Day 164, Day 178, Day 254, Day 268, Day 433 |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |