Sculptra Aesthetic Post-Approval Study

A Prospective, Open-Label, Multicenter Study to Evaluate the Long-Term Safety of Sculptra®Aesthetic in Immuno-Competent Subjects Stratified by Fitzpatrick Skin Type I-VI)

Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.

Study Overview

• Status: Completed
• Conditions: Wrinkles; Nasolabial Fold Contour Deficiencies
• Intervention / Treatment: Device: injectable poly-L-lactic acid Sculptra Aesthetic

• Study Type: Interventional
• Enrollment (Actual): 867
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 32405
      • Galderma Study Site
  • California
    • Encino, California, United States, 91436
      • Galderma Study Site
    • Hermosa Beach, California, United States, 90254
      • Galderma Study Site
    • San Diego, California, United States, 92121
      • Galderma Study Site
    • Solana Beach, California, United States, 92075
      • Galderma Study Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Galderma Study Site
    • Boca Raton, Florida, United States, 33486
      • Galderma Study Site
    • Coral Gables, Florida, United States, 33146
      • Galderma Study Site
    • Miami, Florida, United States, 33137
      • Galderma Study Site
  • Illinois
    • Buffalo Grove, Illinois, United States, 60089
      • Galderma Study Site
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Galderma Study Site
  • New York
    • New York, New York, United States, 10016
      • Galderma Study Site
    • White Plains, New York, United States, 10604
      • Galderma Study Site
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Galderma Study Site
  • Texas
    • Austin, Texas, United States, 78746
      • Galderma Study Site
    • Houston, Texas, United States, 77056
      • Galderma Study Site
    • Plano, Texas, United States, 75093
      • Galderma Study Site
  • Washington
    • Spokane, Washington, United States, 99202
      • Galderma Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects seeking correction of shallow to deep NLF contour deficiencies.

Exclusion Criteria:

1. Subjects seeking, at entry into the study, correction of other facial wrinkles with Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines, glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower lip lines, corner of the mouth lines and/or horizontal neck folds.
2. Subjects that are less than 18 or greater than 75 years of age.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sculptra Aesthetic	Device: injectable poly-L-lactic acid Sculptra Aesthetic; Other Names: Sculptra Aesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Any Injection Site Nodule and/or Papule	Nodules and/or papules are a subset of AEIs that does not include hypertrophic scarring, keloid formation, changes in skin pigmentation at the site of injection compared to adjacent skin, granuloma (confirmed by a biopsy), skin necrosis, hypersensitivity reactions, and unexpected changes in wrinkle contour. Reporting of a nodule or papule was based on size (nodule greater than or equal to [>=] 0.5 (cm); papule less than [<] 0.5 cm). Percentage of participants with any injection site nodule and/or papule were reported.	Up to 5 years
Percentage of Participants With Any Adverse Events of Interest (AEIs)	AEIs means: "serious or non-serious adverse event that is one of scientific and medical concern specific to the sponsor's product for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Examples of AEIs were hypertrophic scarring, keloid formation, hypersensitivity reactions, skin necrosis, unexpected change in wrinkle contour, granuloma, changes in the skin pigmentation at the site of injection compared to adjacent. Percentage of participants with any AEIs (other than injection site nodule and/or papule) were reported.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5	NLF severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side.	Baseline, Months 6,13 and Years 2,3 4,5
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5	The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. The physician assessed the left side and the right side of the participant's face using the 5-point scale where scoring of wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the investigator at defined timepoints. Higher scores mean a worse outcome.	Baseline, Months 6,13 and Years 2,3 4,5
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5	Marionette Lines severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side.	Baseline, Months 6,13 and Years 2,3 4,5
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5	Chin Crease severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side.	Baseline, Months 6,13 and Years 2,3 4,5
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale	Efficacy was assessed by overall facial improvement assessed live by the Investigator assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a subjective test. The investigator independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement.	At 6,13 months, 2, 3, 4 and 5 years
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale	Efficacy was assessed by overall facial improvement assessed live by the participants assessment of facial appearance including the GAIS. The GAIS is a subjective test. The participant independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement (Range 0 to 3).	At 6,13 months, 2, 3, 4 and 5 years

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Chair: Clinical Operations, Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2015
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimated): April 24, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: GLI.04.SPR.US10321