N/A
N=29
Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
Cellulite
Bottom Line
View on ClinicalTrials.gov: NCT05064761 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9 — 23; 4; 1; 1 Thighs
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sculptra new dilution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9 |
23; 4; 1; 1; 24; 3 | — |
| SECONDARY Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12 |
0; 8; 16; 5; 1; 6 | — |
| SECONDARY Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12 |
2; 3; 19; 5; 2; 2 | — |
Summary
This pilot study has been designed to evaluate the safety and effectiveness of PLLA as a single regimen for the improvement in appearance of cellulite after changes in reconstitution procedure.
Eligibility Criteria
Inclusion Criteria
- Subjects with intent to undergo treatment to improve appearance of cellulite in the posterior thighs.
Exclusion Criteria
- Known/previous allergy or hypersensitivity to any of the Sculptra constituents.
- Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents.
- Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
- Previous treatment/procedure in or near the treatment area:
- Previous permanent implant, filler, lifting threads, or autologous fat in the treatment area, regardless of time.
- Previous semi-permanent implants exemplified by Calcium Hydroxylapatite (CaHA), poly l-lactic acid (PLLA) in treatment area, regardless of time.
- Previous Hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months.
- Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and endermology) in the treatment area within 6 months.
- Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in the treatment area within 6 months.
- Previous treatment with cryotherapy, lipolytic treatments or liporeduction massage in the treatment area within 6 months.
Data sourced from ClinicalTrials.gov (NCT05064761). 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.