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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cellulite

Intervention / Treatment
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* Device: Sculptra new dilution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>PLLA new dilution for treatment to improve appearance of cellulite. | Device: Sculptra new dilution<br>* Treatment to improve appearance of cellulite.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |