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NCT02003833 · ClinicalTrials.gov registry record · Phase 4
Poly-L-lactic Acid for Skin Quality
A Phase 4 study, sponsored by Sadick Research Group.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT02003833 is a Phase 4 study that has completed, run by Sadick Research Group. The registered enrollment target is 40 participants.
The verdict
NCT02003833, a Phase 4 study, has completed, sponsored by Sadick Research Group.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Poly-L-lactic acid
- DEVICE Placebo comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02003833
The ClinicalTrials.gov registry entry for NCT02003833 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sadick Research Group, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Poly-L-lactic acid is the first listed.
NCT02003833 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02003833 about?
NCT02003833 is a clinical study titled "Poly-L-lactic Acid for 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 subcutaneou...
What is the current status of trial NCT02003833?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2013-09. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02003833?
The interventions under investigation include: Poly-L-lactic acid (DEVICE), Placebo comparator (DEVICE).
Who is sponsoring clinical trial NCT02003833?
This trial is sponsored by Sadick Research Group, which has 3 total clinical trials registered on ClinicalTrials.gov.
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