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Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell

Skin Laxity Clinical Trial

Official title:
A Single Center, Double-Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell

Clinical Trial Summary

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).

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05269654
Study type Interventional
Source Goldman, Butterwick, Fitzpatrick and Groff
Contact
Status Not yet recruiting
Phase N/A
Start date March 4, 2022
Completion date March 1, 2024
View Details
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