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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Sculptra injections
saline injections
Laser and Skin Surgery Center of Indiana
Carmel, Indiana, United States
Sadick Research Group
New York, New York, United States
Improvement in skin quality
The primary endpoint is defined as the degree of improvement in skin quality measured by a blinded, trained evaluator using standardized pictures as well as live evaluations rated by a blinded investigator and the subjects
Time frame: 15 months
Improvement of skin physiology
Non-invasive biophysical measurements will be used to assess sub-clinical changes in skin quality including skin hydration, elasticity, density and dermal thickness and a decrease in transepidermal water loss
Time frame: 15 months
Investigator and patient satisfaction
Investigator and patient satisfaction will be assessed with a quartile scale.
Time frame: 15 months
Safety of repeated injections with Sculptra Aesthetic
Safety analyses will be done on all treated patients, defined by any subject who received at least one study treatment. Compiled side effects, including all expected or unexpected side effects but not limited to site discomfort, redness, bruising, bleeding, itching, and swelling, small and larger lumps under the skin
Time frame: 15 months
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