Clinical Trials Logo
  1. Home
  2. Skin Laxity
  3. NCT05269654

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06140628 - A 28-day Clinical Study on Facial Skin Rejuvenation N/A
Completed NCT01971736 - Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening N/A
Completed NCT01713985 - Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck N/A
Completed NCT01708252 - Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment N/A
Completed NCT01713998 - Treatment of the Face and Neck With Lower Ulthera System Energy Settings N/A
Completed NCT01708382 - Feasibility Study: Lifting and Tightening of the Elbows N/A
Completed NCT04296201 - Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology N/A
Completed NCT06000839 - A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology) N/A
Completed NCT06366503 - Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation N/A
Completed NCT05929625 - Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation N/A
Terminated NCT01713569 - Feasibility Study: Histological Characterization After Treatment With the Ulthera® System N/A
Completed NCT01519934 - A Retrospective Study to Evaluate the Effectiveness of the Ulthera System N/A
Completed NCT05605691 - Post-Market Lower Eyelid Treatment With Renuvion in Greece N/A
Completed NCT04477187 - Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling N/A
Completed NCT05590364 - Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands N/A
Active, not recruiting NCT06243744 - Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery N/A
Completed NCT04146584 - Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow Phase 2
Recruiting NCT05750901 - Evaluation of Fractional Ablative Laser Treatment for Skin Conditions N/A
Completed NCT04721600 - Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance N/A
Recruiting NCT06157567 - Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System N/A