N/A
N=30
An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area
Wrinkles in Decolletage
Bottom Line
View on ClinicalTrials.gov: NCT05538728 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9 — 93.8; 78.6 percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- poly-l-lactic acid (Sculptra) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- Female
- Sponsor
- Galderma R&D
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9 |
93.8; 78.6 | — |
| SECONDARY Percentage of Responders on the Galderma Décolletage Scale, as Assessed Live by the Treating Investigator, at Month 6 |
93.3; 100 | — |
| SECONDARY Percentage of Responders Who Achieved At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant at Months 6 and 9 |
100; 100; 100; 91.7 | — |
| SECONDARY Percentage of Responders With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Months 6 and 9 |
100; 100; 100; 100 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Non-pregnant, non-breastfeeding females over the age of 22
- subjects seeking treatment for the décolletage
- subjects with moderate (Grade 2) or severe (Grade 3) on the Galderma Décolletage Scale
- subjects willing to abstain from any other surgical or cosmetic procedures in the décolletage area for the duration of the study.
Exclusion Criteria
- Known/previous allergy or hypersensitivity to Sculptra
- Previous tissue augmenting therapy, contouring or revitalization treatment in the décolletage prior to baseline
- Any plastic surgery or permanent surgical implant in the treatment area
- Previous treatment/procedure in the treatment area in the previous 6 months that would interfere with study injections or study assessments
Data sourced from ClinicalTrials.gov (NCT05538728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.