NCT03487172

Sculptra Aesthetic for the Treatment of Upper Knee Skin Laxity

A Randomized, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Upper Knee Skin Laxity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.

Detailed description

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.

Conditions

• Lax Skin
• Knee

Interventions

Type	Name	Description
DEVICE	poly-L-lactic acid to right knee	Subjects will receive PLLA injections to the right knee and bacteriostatic water to the left.
DEVICE	poly-L-lactic acid to left knee	Subjects will receive PLLA injections to the left knee and bacteriostatic water to the right.

Timeline

• Start date: 2018-04-10
• Primary completion: 2019-04-17
• Completion: 2019-04-17
• First posted: 2018-04-03
• Last updated: 2019-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study