Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite

NCT05064761 | Completed Results

• 1 other identifier: 43CASA2006
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cellulite

Outcome Measures

Primary Outcomes (1)

• Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9

  Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to current visit. On a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 9 were reported.

  At Month 9

Secondary Outcomes (2)

• 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

  At month 1, 2, 6 and 12

• 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

  At Months 1, 2, 6, 9 and 12

Study Arms (1)

Treatment group

EXPERIMENTAL

PLLA new dilution for treatment to improve appearance of cellulite.

Device: Sculptra new dilution

Interventions

Sculptra new dilution DEVICE

Treatment to improve appearance of cellulite.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with intent to undergo treatment to improve appearance of cellulite in the posterior thighs.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Galderma Research Site

Vancouver, British Columbia, V5Z4E1, Canada

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Galderma Research and Development, LLC (GLLC)

aestheticclinicaltrials@galderma.com

+1 817-961-5000

Study Officials

• Study Director

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: November 19, 2021
• Primary Completion: December 21, 2022
• Study Completion: February 27, 2023
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)