Skin Aging Clinical Trial
Official title:
Randomized, Controlled, Multi-Centered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Improving Facial Wrinkles and Skin Quality
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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