Poly-L-lactic Acid for Skin Quality
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|ClinicalTrials.gov Identifier: NCT02003833|
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : November 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Skin Aging||Device: Poly-L-lactic acid Device: Placebo comparator||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Controlled, Multi-Centered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Improving Facial Wrinkles and Skin Quality|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Poly-L-lactic acid
Subjects in the treatment arm will receive three injections of 5 cc of poly-L-lactic acid (PLLA) into both sides of the face.
Device: Poly-L-lactic acid
Placebo Comparator: Placebo
Subjects in the placebo arm will receive three injections of 5 cc of saline into both sides of the face. After the completion of the study, subjects in the placebo arm will receive free injections with Sculptra Aesthetic same as the treatment arm.
Device: Placebo comparator
Other Name: Placebo
- Improvement in skin quality [ Time Frame: 15 months ]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
- Improvement of skin physiology [ Time Frame: 15 months ]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
- Investigator and patient satisfaction [ Time Frame: 15 months ]Investigator and patient satisfaction will be assessed with a quartile scale.
- Safety of repeated injections with Sculptra Aesthetic [ Time Frame: 15 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003833
|United States, Indiana|
|Laser and Skin Surgery Center of Indiana|
|Carmel, Indiana, United States, 46032|
|United States, New York|
|Sadick Research Group|
|New York, New York, United States, 10075|
|Principal Investigator:||Neil S Sadick, MD||Sadick Research Group|
|Principal Investigator:||William Hanke, MD||Laser and Skin Surgery Center of Indiana|