NCT02003833

Poly-L-lactic Acid for Skin Quality

Randomized, Controlled, Multi-Centered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Improving Facial Wrinkles and Skin Quality

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sadick Research Group · Academic / Other
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Anecdotal evidence suggests that patients' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow". The aim of this study is to evaluate the effect of repeated subcutaneous injections of poly-L-lactic acid (Sculptra Aesthetic) on skin quality. Participating subjects will be part of the study for about 15 months. There will be an initial treatment period of up to 12 weeks, followed by a 12-month follow-up period. There will be a total of 7 scheduled visits. This study is a double-blind, randomized study. "Double-blind" means that neither the subjects nor the study doctor will know who is receiving Sculptra Aesthetic or placebo. "Randomized" means that the group subjects will be placed in is decided by chance, similar to drawing numbers out of a hat or flipping a coin. Subjects will have a 1 out of 2 chance of receiving the active study drug. After the completion of the study, if subjects are assigned to the control (placebo) group they will receive free injections with Sculptra Aesthetic same as the treatment group.

Conditions

• Skin Aging

Interventions

Type	Name	Description
DEVICE	Poly-L-lactic acid	Sculptra injections
DEVICE	Placebo comparator	saline injections

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-03-01
• Completion: 2015-09-01
• First posted: 2013-12-06
• Last updated: 2015-11-20

Locations

2 sites across 1 country: United States