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)
1 other identifier
interventional
867
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2015
Longer than P75 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedStudy Start
First participant enrolled
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2021
CompletedResults Posted
Study results publicly available
July 27, 2023
CompletedJuly 27, 2023
July 1, 2023
6 years
April 10, 2015
April 14, 2023
July 5, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
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
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
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
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
At 6,13 months, 2, 3, 4 and 5 years
- +1 more secondary outcomes
Study Arms (1)
Sculptra Aesthetic
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- \. Subjects seeking correction of shallow to deep NLF contour deficiencies.
You may not qualify if:
- 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.
- Subjects that are less than 18 or greater than 75 years of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (18)
Galderma Study Site
Birmingham, Alabama, 32405, United States
Galderma Study Site
Encino, California, 91436, United States
Galderma Study Site
Hermosa Beach, California, 90254, United States
Galderma Study Site
San Diego, California, 92121, United States
Galderma Study Site
Solana Beach, California, 92075, United States
Galderma Study Site
Aventura, Florida, 33180, United States
Galderma Study Site
Boca Raton, Florida, 33486, United States
Galderma Study Site
Coral Gables, Florida, 33146, United States
Galderma Study Site
Miami, Florida, 33137, United States
Galderma Study Site
Buffalo Grove, Illinois, 60089, United States
Galderma Study Site
Hackensack, New Jersey, 07601, United States
Galderma Study Site
New York, New York, 10016, United States
Galderma Study Site
White Plains, New York, 10604, United States
Galderma Study Site
Nashville, Tennessee, 37215, United States
Galderma Study Site
Austin, Texas, 78746, United States
Galderma Study Site
Houston, Texas, 77056, United States
Galderma Study Site
Plano, Texas, 75093, United States
Galderma Study Site
Spokane, Washington, 99202, United States
Results Point of Contact
- Title
- Clinical Operations
- Organization
- Galderma
Study Officials
- STUDY CHAIR
Clinical Operations
Galderma R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2015
First Posted
April 24, 2015
Study Start
May 21, 2015
Primary Completion
May 28, 2021
Study Completion
May 28, 2021
Last Updated
July 27, 2023
Results First Posted
July 27, 2023
Record last verified: 2023-07