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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2023-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Retrospective Study of the Safety and Efficacy of PLLA for Skin Flaccidity in Labia Majora and/or Pubis Region

NCT05940038

Skin Laxity

UNKNOWN

Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell

NCT05269654

Skin Laxity

UNKNOWN NA

An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area

NCT05538728

Wrinkles in Decolletage

COMPLETED NA

Sculptra to Aid in Treatment of Arm Laxity

NCT05445661

Skin Laxity

UNKNOWN NA

Efficacy and Safety of Poly-L-lactic Acid

NCT03225066

Flaccidity, Muscle

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cellulite

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

PLLA new dilution for treatment to improve appearance of cellulite.

Group Type EXPERIMENTAL

Sculptra new dilution

Intervention Type DEVICE

Treatment to improve appearance of cellulite.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sculptra new dilution

Treatment to improve appearance of cellulite.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes