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NCT05538728 · ClinicalTrials.gov registry record · NA
An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area
A NA study of Wrinkles in Decolletage, sponsored by Galderma R&D.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT05538728: Completed NA study of Wrinkles in Decolletage, sponsored by Galderma R&D.
NCT05538728 is a NA study of Wrinkles in Decolletage that has completed, run by Galderma R&D. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05538728, a NA study of Wrinkles in Decolletage, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a prospective open-label study to evaluate safety and effectiveness of two different reconstitution volumes of poly-l-lactic acid (PLLA) for correction of wrinkles in the décolletage area.
Primary Outcome
Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area.
Conditions Studied
Interventions
- DEVICE poly-l-lactic acid (Sculptra)
Study Locations (2)
California
- Galderma Study Site - Encino
- Galderma Study Site - Solana Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2023-08-08 |
| Phase | NA |
What the finished NCT05538728 record still lists
NCT05538728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Wrinkles in Decolletage appearing as the primary indexed condition, and to 1 intervention - of which poly-l-lactic acid (Sculptra) is the first listed.
NCT05538728 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05538728 about?
NCT05538728 is a clinical study titled "An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area". This is a prospective open-label study to evaluate safety and effectiveness of two different reconstitution volumes of poly-l-lactic acid (PLLA) for correction of wrinkles in the décolletage area.
What is the current status of trial NCT05538728?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2022-08-31. Estimated completion is 2023-08-08.
What conditions does trial NCT05538728 study?
This clinical trial studies the following conditions: Wrinkles in Decolletage.
What interventions are being tested in trial NCT05538728?
The interventions under investigation include: poly-l-lactic acid (Sculptra) (DEVICE).
Who is sponsoring clinical trial NCT05538728?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05538728 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05538728's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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