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

Cellulite Clinical Trial

Official title:

A Pilot Study to Evaluate Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064761
• Other study ID #: 43CASA2006
• Status: Completed
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: March 23, 2023

Study information

• Verified date: August 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cellulite is a topographic and localized skin condition that is commonly found on the posterolateral thighs, buttocks, and abdomen. It is often identified by a dimpled or orange-peel appearance of the skin's surface. The presence of visible cellulite is associated with histologic changes in the dermis, adipose tissue, and septae. Based on the theory that a stronger skin structure, with a decrease in skin laxity and increase in dermal thickness, could reduce the appearance of cellulite, the Sponsor intends to investigate the safety and effectiveness of PLLA for the improvement in appearance of cellulite in the posterior thighs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 23, 2023
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

1. Previous permanent implant, filler, lifting threads, or autologous fat in the treatment area, regardless of time.

2. Previous semi-permanent implants exemplified by Calcium Hydroxylapatite (CaHA), poly l-lactic acid (PLLA) in treatment area, regardless of time.

3. Previous Hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months.

4. Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and endermology) in the treatment area within 6 months.

5. Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in the treatment area within 6 months.

6. Previous treatment with cryotherapy, lipolytic treatments or liporeduction massage in the treatment area within 6 months.

Related Conditions & MeSH terms

• Cellulite

Intervention

Device:
• Sculptra new dilution
Treatment to improve appearance of cellulite.

Locations

Country	Name	City	State
Canada	Galderma Research Site	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder Rate GAIS	Percentage of responders, defined as having at least "Improved" on both thighs according to the Global Aesthetic Improvement Scale (GAIS), as assessed live by the Treating Investigator.	Month 9