Back to resultsSafety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
Primary Purpose
Cellulite
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sculptra new dilution
Sponsored by
About this trial
This is an interventional treatment trial for Cellulite
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.
Sites / Locations
- Galderma Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
PLLA new dilution for treatment to improve appearance of cellulite.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05064761
Brief Title
Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
Official Title
A Pilot Study to Evaluate Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
March 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
PLLA new dilution for treatment to improve appearance of cellulite.
Intervention Type
Device
Intervention Name(s)
Sculptra new dilution
Intervention Description
Treatment to improve appearance of cellulite.
Primary Outcome Measure Information:
Title
Responder Rate GAIS
Description
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.
Time Frame
Month 9
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Galderma Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z4E1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
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